Bayer Healthcare, LLC
FDA 510(k) medical device clearances.
Top product codes for Bayer Healthcare, LLC
Recent clearances by Bayer Healthcare, LLC
- K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
- K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
- K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER
- K121190 — CONTOUR NEXT BLOOD GLUCOSE METER
- K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
- K093930 — DIDGET WORLD REPORTS
- K090628 — DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
- K090413 — A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
- K082486 — GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
- K063845 — ADVIA CHEMISTRY TOTAL BILIRUBIN_2
- K063276 — CLINITEK ADVANTUS, MODEL 1420
- K062347 — ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
- K061137 — ADVIA IMS CPSA CONTROL
- K061139 — BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
- K053020 — TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
- K052503 — TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
- K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
- K052163 — ADVIA IMS GLUCOSE ASSAY
- K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS
- K051619 — LIPOPROTEIN FOR MULTIPLE ANALYTES
- K050374 — ADVIA IMS LITHIUM ASSAY
- K051265 — ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- K050632 — ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
- K043228 — ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
- K042807 — ADVIA IMS VALPROIC ACID METHOD
- K042808 — ADVIA IMS CARBAMAZEPINE METHOD
- K043158 — ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
- K043311 — ASCENSIA ELITE DIABETES CARE SYSTEM
- K042251 — BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
- K041133 — MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
- K040425 — ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
- K033791 — BAYER SPECIFIC PROTEIN REFERENCE SERUM
- K032563 — CLINITEST HCG PREGNANCY TEST
- K031947 — BAYER CLINITEK STATUS ANALYZER
- K031560 — BAYER RAPIDLAB 1200 SYSTEM
- K032525 — BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
- K032524 — ADVIA 60 HEMATOLOGY ANALYZER
- K031683 — TOX AMMONIA CALIBRATOR
- K031644 — BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
- K031682 — LIPOPROTEIN CALIBRATOR
- K031393 — BAYER ADVIA CENTAUR CA 19-9 ASSAY
- K031038 — ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- K030804 — BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
- K030801 — BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
- K030169 — SETPOINT CHEMISTRY CALIBRATOR
- K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
Data sourced from openFDA. This site is unofficial and independent of the FDA.