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Bayer Healthcare, LLC

46 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (K171802)Bayer Healthcare, LLC2018-03-07
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (K152852)Bayer Healthcare, LLC2015-12-22
CONTOUR NEXT EZ BLOOD GLUCOSE METER (K130265)Bayer Healthcare, LLC2014-06-23
CONTOUR NEXT BLOOD GLUCOSE METER (K121190)Bayer Healthcare, LLC2012-07-26
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) (K110587)Bayer Healthcare, LLC2012-03-28
DIDGET WORLD REPORTS (K093930)Bayer Healthcare, LLC2010-03-12
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 (K090628)Bayer Healthcare, LLC2009-12-04
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC (K090413)Bayer Healthcare, LLC2009-05-14
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE (K082486)Bayer Healthcare, LLC2008-10-08
ADVIA CHEMISTRY TOTAL BILIRUBIN_2 (K063845)Bayer Healthcare, LLC2007-12-07
CLINITEK ADVANTUS, MODEL 1420 (K063276)Bayer Healthcare, LLC2006-12-28
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM (K062347)Bayer Healthcare, LLC2006-11-22
ADVIA IMS CPSA CONTROL (K061137)Bayer Healthcare, LLC2006-07-06
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS (K061139)Bayer Healthcare, LLC2006-07-06
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM (K053020)Bayer Healthcare, LLC2005-12-30
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM (K052503)Bayer Healthcare, LLC2005-12-14
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (K051693)Bayer Healthcare, LLC2005-12-07
ADVIA IMS GLUCOSE ASSAY (K052163)Bayer Healthcare, LLC2005-10-11
ADVIA CHEMISTRY MICROALBUMIN CONTROLS (K052242)Bayer Healthcare, LLC2005-10-03
LIPOPROTEIN FOR MULTIPLE ANALYTES (K051619)Bayer Healthcare, LLC2005-08-01
ADVIA IMS LITHIUM ASSAY (K050374)Bayer Healthcare, LLC2005-06-15
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K051265)Bayer Healthcare, LLC2005-06-13
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY (K050632)Bayer Healthcare, LLC2005-05-26
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K043228)Bayer Healthcare, LLC2005-04-22
ADVIA IMS VALPROIC ACID METHOD (K042807)Bayer Healthcare, LLC2005-02-08
ADVIA IMS CARBAMAZEPINE METHOD (K042808)Bayer Healthcare, LLC2005-02-08
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM (K043158)Bayer Healthcare, LLC2004-12-22
ASCENSIA ELITE DIABETES CARE SYSTEM (K043311)Bayer Healthcare, LLC2004-12-22
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (K042251)Bayer Healthcare, LLC2004-09-17
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K041133)Bayer Healthcare, LLC2004-07-02
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K040425)Bayer Healthcare, LLC2004-06-14
BAYER SPECIFIC PROTEIN REFERENCE SERUM (K033791)Bayer Healthcare, LLC2004-02-13
CLINITEST HCG PREGNANCY TEST (K032563)Bayer Healthcare, LLC2003-12-23
BAYER CLINITEK STATUS ANALYZER (K031947)Bayer Healthcare, LLC2003-12-19
BAYER RAPIDLAB 1200 SYSTEM (K031560)Bayer Healthcare, LLC2003-12-17
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K032525)Bayer Healthcare, LLC2003-09-09
ADVIA 60 HEMATOLOGY ANALYZER (K032524)Bayer Healthcare, LLC2003-09-08
TOX AMMONIA CALIBRATOR (K031683)Bayer Healthcare, LLC2003-08-06
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL (K031644)Bayer Healthcare, LLC2003-06-25
LIPOPROTEIN CALIBRATOR (K031682)Bayer Healthcare, LLC2003-06-25
BAYER ADVIA CENTAUR CA 19-9 ASSAY (K031393)Bayer Healthcare, LLC2003-06-24
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K031038)Bayer Healthcare, LLC2003-06-23
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR (K030804)Bayer Healthcare, LLC2003-04-10
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL (K030801)Bayer Healthcare, LLC2003-04-09
SETPOINT CHEMISTRY CALIBRATOR (K030169)Bayer Healthcare, LLC2003-01-31
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (K030102)Bayer Healthcare, LLC2003-01-24

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Every clearance here is in the API, with alerts when new ones post.