Medical Device Manufacturer · US , New York , NY

Bayer Healthcare, LLC

46 submissions · 46 cleared · Since 2003
46
Total
46
Cleared
0
Denied

Bayer Healthcare, LLC — FDA 510(k) Submissions

Bayer Healthcare, LLC has submitted 46 FDA 510(k) premarket notifications since 2003, of which 46 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Blood Glucose, Over The Counter, Calibrator, Multi-analyte Mixture, Test, Natriuretic Peptide, Multi-analyte Controls, All Kinds (assayed), Glucose Dehydrogenase, Glucose . Use the specialty filter in the sidebar to narrow results.

46 devices
1–25 of 46
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802 · NUH Stimulator, Nerve,... · Neurology
Mar 2018 261d
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · NUH Stimulator, Nerve,... · Neurology
Dec 2015 84d
CONTOUR NEXT EZ BLOOD GLUCOSE METER
K130265 · NBW System, Test, Blood... · Chemistry
Jun 2014 504d
CONTOUR NEXT BLOOD GLUCOSE METER
K121190 · LFR Glucose Dehydrogenase,... · Chemistry
Jul 2012 98d
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
K110587 · LFR Glucose Dehydrogenase,... · Chemistry
Mar 2012 393d
DIDGET WORLD REPORTS
K093930 · NBW System, Test, Blood... · Chemistry
Mar 2010 80d
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
K090628 · NBW System, Test, Blood... · Chemistry
Dec 2009 270d
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
K090413 · LCP Assay, Glycosylated... · Chemistry
May 2009 85d
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
K082486 · NBW System, Test, Blood... · Chemistry
Oct 2008 41d
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845 · JFM Enzymatic Method, Bilirubin · Chemistry
Dec 2007 345d
CLINITEK ADVANTUS, MODEL 1420
K063276 · JIL Method, Enzymatic,... · Chemistry
Dec 2006 59d
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
K062347 · NBW System, Test, Blood... · Chemistry
Nov 2006 104d
ADVIA IMS CPSA CONTROL
K061137 · JJY Multi-analyte Controls,... · Immunology
Jul 2006 73d
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
K061139 · JIT Calibrator, Secondary · Immunology
Jul 2006 73d
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
K053020 · MMI Immunoassay Method,... · Chemistry
Dec 2005 65d
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
K052503 · MMI Immunoassay Method,... · Chemistry
Dec 2005 92d
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693 · GKL Counter, Cell, Automated... · Hematology
Dec 2005 167d
ADVIA IMS GLUCOSE ASSAY
K052163 · CFR Hexokinase, Glucose · Chemistry
Oct 2005 63d
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
K052242 · JJW Urinalysis Controls... · Chemistry
Oct 2005 47d
LIPOPROTEIN FOR MULTIPLE ANALYTES
K051619 · JIX Calibrator, Multi-analyte... · Chemistry
Aug 2005 45d
ADVIA IMS LITHIUM ASSAY
K050374 · NDW Assay, Porphyrin,... · Chemistry
Jun 2005 121d
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K051265 · NBC Test, Natriuretic Peptide · Chemistry
Jun 2005 28d
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K050632 · LBS Ldl & Vldl Precipitation,... · Chemistry
May 2005 78d
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K043228 · NBC Test, Natriuretic Peptide · Chemistry
Apr 2005 151d
ADVIA IMS VALPROIC ACID METHOD
K042807 · LEG Enzyme Immunoassay,... · Chemistry
Feb 2005 119d
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