FDA 510(k) Applications Submitted by ANDRES HOLLE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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 |
| K031857 |
06/16/2003 |
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY |
BAYER DIAGNOSTICS CORP. |
| K042015 |
07/27/2004 |
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE |
BAYER HEALTHCARE, DIAGNOSTICS DIVISION |
| K052163 |
08/09/2005 |
ADVIA IMS GLUCOSE ASSAY |
BAYER HEALTHCARE, LLC |
| K032525 |
08/15/2003 |
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER |
BAYER HEALTHCARE, LLC |
| K052242 |
08/17/2005 |
ADVIA CHEMISTRY MICROALBUMIN CONTROLS |
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 |
| K033379 |
10/22/2003 |
BAYER SPECIAL CHEMISTRY CONTROLS |
BAYER DIAGNOSTICS CORP. |
| K033380 |
10/22/2003 |
BAYER SPECIAL CHEMISTRY CALIBRATORS |
BAYER DIAGNOSTICS CORP. |
| K053020 |
10/26/2005 |
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM |
BAYER HEALTHCARE, LLC |
| K023840 |
11/18/2002 |
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 |
BAYER DIAGNOSTICS CORP. |
| K023841 |
11/18/2002 |
AMMONIA ASSAY FOR THE ADVIA 1650 |
BAYER DIAGNOSTICS CORP. |
| K033791 |
12/04/2003 |
BAYER SPECIFIC PROTEIN REFERENCE SERUM |
BAYER HEALTHCARE, LLC |
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