Bayer Corp.
FDA 510(k) medical device clearances.
Top product codes for Bayer Corp.
Recent clearances by Bayer Corp.
- K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER
- K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY
- K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
- K023584 — ASCENSIA DEX 2 DIABETES CARE SYSTEM
- K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
- K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
- K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
- K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K012337 — BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
- K011963 — ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
- K013272 — ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
- K012777 — ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
- K012340 — BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
- K012205 — GLUCOMETER DEX TEST SENSOR
- K010755 — BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
- K010668 — BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
- K003412 — ADVIA CENTAUR RUBELLA IGG ASSAY
- K010201 — BAYER ADVIA IMS SYSTEM
- K003796 — ADVIA 120 HEMATOLOGY
- K002738 — BAYER RAPIDPOINT 400 SYSTEM
- K002376 — ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
- K992228 — BAYER IMMUNO 1 HER-2/NEU ASSAY
- K001344 — ADVIA IMS
- K000903 — ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
- K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3
- K994221 — BAYER PSA ASSAY
- K993867 — BAYER ADVIA IMS SYSTEM
- K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K993571 — BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
- K993711 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)
- K993309 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
- K993353 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
- K992257 — NEW MULTIPLES REAGENT STRIPS
- K991315 — MICROALBUSTIX REAGENT STRIPS (OTC)
- K991907 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K992136 — BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
- K992399 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K990649 — GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
- K991242 — GLUCOMETER ELITE TEST STRIPS
- K991576 — ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K990346 — BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K983715 — THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K984006 — GLUCOMETER ELITE XL BLOOD GLUCOSE METER
- K982328 — BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K983345 — BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
- K982714 — BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
- K982802 — BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K982219 — MICROALBUSTIX REAGENT STRIPS
- K981312 — 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K980376 — THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K980521 — DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
- K974721 — UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K973616 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K964703 — THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K964098 — CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K971989 — TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K972462 — AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K972580 — DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K972706 — CLINITEK MICROALBUMIN REAGENT STRIPS
- K971998 — ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
- K971716 — PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K971276 — GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
- K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K964791 — B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K971209 — CLINITEK HCG TEST STRIPS
- K964004 — GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
- K964630 — GLUCOMETER ELITE BLOOD GLUCOSE METER
- K963500 — GLUCOMETER DEX DIABETES CARE SYSTEM
- K964587 — VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
- K964116 — QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K964442 — VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K964068 — CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K963080 — TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K963142 — DCA 2000 + MICROALBUMIN/CREATININE ASSAY
- K954607 — RETICULOCYTE METHOD
- K954594 — RETICULOCYTE METHOD, RBC INDICES
- K962344 — MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K955760 — TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
- K962125 — TECHNICON IMMUNO 1 SYSTEM
- K962355 — FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K960888 — CHEK-STIX U.T.I. SELF-TEST
- K961412 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
- K955087 — HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
- K960546 — CLINITEK 50 URINE CHEMISTRY ANALYZER
- K961351 — HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
- K951359 — RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
- K954332 — RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K953939 — QUINTEST
- K951537 — GLUCOMETER ELITE M BLOOD GLUCOSE METER
- K952075 — PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM
- K951631 — DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
- K951360 — ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
- K893117 — GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
Data sourced from openFDA. This site is unofficial and independent of the FDA.