Bayer Healthcare, LLC
Bayer Healthcare, LLC holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2018, with 2 FDA device recalls on record.
Top product codes for Bayer Healthcare, LLC
FDA recalls by Bayer Healthcare, LLC
- Z-2482-2015 — Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.
- Z-0136-2014 — Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
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.