ACON Laboratories, Inc.
FDA 510(k) medical device clearances.
Top product codes for ACON Laboratories, Inc.
Recent clearances by ACON Laboratories, Inc.
- K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System
- K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test
- K232715 — Distinct® Digital Pregnancy Test
- K233373 — Flowflex® Plus COVID-19 Home Test
- K230828 — Flowflex COVID-19 Antigen Home Test
- K193318 — Distinct® Early Detection Pregnancy Test
- K192175 — On Call Express II Blood Glucose Monitoring System
- K191038 — On Call Express Voice Blood Glucose Monitoring System
- K181527 — On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
- K180504 — Mission Lipid Panel Monitoring System
- K180196 — On Call Express Mobile Blood Glucose Monitoring System
- K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
- K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
- K151595 — On Call Express Pro Blood Glucose Monitoring System
- K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
- K150330 — Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
- K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
- K131469 — ACON ON CALL DIABETES MANAGEMENT SOFTWARE
- K130284 — ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
- K132086 — ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
- K122553 — MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
- K123010 — ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
- K122110 — ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
- K113332 — ON CALL CHOSEN LANCING DEVICE
- K112653 — ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
- K120124 — FORESIGHT U120 URINE ANALYZER
- K111221 — MISSION U500 URINE ANALYZER
- K111371 — ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
- K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
- K101371 — ON CALL PLUS DIABETES MONITORING SOFTWARE
- K093879 — MISSION SALIVA ALCOHOL TEST STRIP
- K093143 — MISSION BREATH ALCOHOL DETECTOR
- K063295 — ACON UTI URINARY TRACT INFECTION TEST STRIPS
- K070929 — ACON U120 URINE ANALYZER, MODEL U111-101
- K063418 — ACON DIGITAL THERMOMETER PROBE COVERS
- K060925 — ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112
- K060466 — ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE
- K060173 — ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
- K050936 — ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
- K050878 — ON CALL MULTI-DRUG HOME TEST CUP
- K050546 — ACON +/- MIDSTREAM PREGNANCY TEST
- K050593 — ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
- K050050 — ON CALL MULTI-DRUG HOME TEST
- K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
- K043507 — ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE
- K041822 — ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
- K041743 — ACON TRI-FECT DRUG SCREEN TEST DEVICE
- K042151 — ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
- K041685 — ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
- K041946 — ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
- K041165 — FSH MENOPAUSE PREDICTOR TEST
- K040445 — ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
- K040274 — ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
- K032903 — ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
- K033047 — ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE
- K033299 — ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
- K033041 — ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
- K032661 — ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
- K032510 — ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
- K031759 — ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD
- K031784 — ACON STREP A RAPID TEST DEVICE
- K024350 — ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
- K023946 — ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
- K022589 — ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
- K021526 — ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
- K020771 — ACON ONE STEP DRUG SCREEN TEST CARD
- K013380 — ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
- K012824 — ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
- K012595 — ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
- K012300 — ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE
- K012252 — QUIK-CHECK OVULATION PREDICTOR
- K011730 — ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
- K012215 — QUIK-CHECK HOME PREGNANCY TEST
- K011672 — ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
- K011673 — ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
- K011353 — ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
- K010841 — ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
- K003557 — ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
- K993483 — ACON ONE STEP HOME PREGNANCY TEST STRIP
- K993203 — ACON ONE STEP PREGNANCY TEST STRIP (URINE)
- K993317 — ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
- K993065 — ACON COMBO PREGNANCY
- K983090 — ACON MIDSTREAM PREGNANCY TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.