FDA 510(k) Applications Submitted by BAYER HEALTHCARE, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K051619 |
06/17/2005 |
LIPOPROTEIN FOR MULTIPLE ANALYTES |
BAYER HEALTHCARE, LLC |
| K051693 |
06/23/2005 |
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
BAYER HEALTHCARE, LLC |
| K050374 |
02/14/2005 |
ADVIA IMS LITHIUM ASSAY |
BAYER HEALTHCARE, LLC |
| K050632 |
03/09/2005 |
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY |
BAYER HEALTHCARE, LLC |
| K030801 |
03/13/2003 |
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL |
BAYER HEALTHCARE, LLC |
| K030804 |
03/13/2003 |
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR |
BAYER HEALTHCARE, LLC |
| K061137 |
04/24/2006 |
ADVIA IMS CPSA CONTROL |
BAYER HEALTHCARE, LLC |
| K061139 |
04/24/2006 |
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS |
BAYER HEALTHCARE, LLC |
| K041133 |
04/30/2004 |
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER |
BAYER HEALTHCARE, LLC |
| K051265 |
05/16/2005 |
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY |
BAYER HEALTHCARE, LLC |
| K031644 |
05/27/2003 |
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL |
BAYER HEALTHCARE, LLC |
| K052163 |
08/09/2005 |
ADVIA IMS GLUCOSE ASSAY |
BAYER HEALTHCARE, LLC |
| K032525 |
08/15/2003 |
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER |
BAYER HEALTHCARE, LLC |
| K042251 |
08/20/2004 |
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
BAYER HEALTHCARE, LLC |
| K052503 |
09/13/2005 |
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM |
BAYER HEALTHCARE, LLC |
| K042807 |
10/12/2004 |
ADVIA IMS VALPROIC ACID METHOD |
BAYER HEALTHCARE, LLC |
| K042808 |
10/12/2004 |
ADVIA IMS CARBAMAZEPINE METHOD |
BAYER HEALTHCARE, LLC |
| K053020 |
10/26/2005 |
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM |
BAYER HEALTHCARE, LLC |
| K033791 |
12/04/2003 |
BAYER SPECIFIC PROTEIN REFERENCE SERUM |
BAYER HEALTHCARE, LLC |
| K043228 |
11/22/2004 |
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS |
BAYER HEALTHCARE, LLC |
| K090413 |
02/18/2009 |
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC |
BAYER HEALTHCARE, LLC |
| K110587 |
03/01/2011 |
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) |
BAYER HEALTHCARE, LLC |
| K043158 |
11/15/2004 |
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE, LLC |
| K043311 |
12/01/2004 |
ASCENSIA ELITE DIABETES CARE SYSTEM |
BAYER HEALTHCARE, LLC |
| K030102 |
01/10/2003 |
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 |
BAYER HEALTHCARE, LLC |
| K030169 |
01/17/2003 |
SETPOINT CHEMISTRY CALIBRATOR |
BAYER HEALTHCARE, LLC |
| K040425 |
02/18/2004 |
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS |
BAYER HEALTHCARE, LLC |
| K031038 |
04/01/2003 |
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY |
BAYER HEALTHCARE, LLC |
| K031393 |
05/02/2003 |
BAYER ADVIA CENTAUR CA 19-9 ASSAY |
BAYER HEALTHCARE, LLC |
| K031683 |
05/30/2003 |
TOX AMMONIA CALIBRATOR |
BAYER HEALTHCARE, LLC |
| K031682 |
05/30/2003 |
LIPOPROTEIN CALIBRATOR |
BAYER HEALTHCARE, LLC |
| K032524 |
08/15/2003 |
ADVIA 60 HEMATOLOGY ANALYZER |
BAYER HEALTHCARE, LLC |
| K062347 |
08/10/2006 |
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE, LLC |
| K032563 |
08/20/2003 |
CLINITEST HCG PREGNANCY TEST |
BAYER HEALTHCARE, LLC |
| K031560 |
05/19/2003 |
BAYER RAPIDLAB 1200 SYSTEM |
BAYER HEALTHCARE, LLC |
| K031947 |
06/24/2003 |
BAYER CLINITEK STATUS ANALYZER |
BAYER HEALTHCARE, LLC |
| K063276 |
10/30/2006 |
CLINITEK ADVANTUS, MODEL 1420 |
BAYER HEALTHCARE, LLC |
| K063845 |
12/27/2006 |
ADVIA CHEMISTRY TOTAL BILIRUBIN_2 |
BAYER HEALTHCARE, LLC |
| K082486 |
08/28/2008 |
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE |
BAYER HEALTHCARE, LLC |
| K090628 |
03/09/2009 |
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 |
BAYER HEALTHCARE, LLC |
| K152852 |
09/29/2015 |
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) |
BAYER HEALTHCARE, LLC |
|
|
