FDA 510(k) Applications Submitted by BAYER CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K010201 01/22/2001 BAYER ADVIA IMS SYSTEM BAYER CORP.
K000903 03/21/2000 ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM BAYER CORP.
K000921 03/22/2000 BAYER ADVIA IMS SYSTEM; 200 + 3 BAYER CORP.
K001344 04/27/2000 ADVIA IMS BAYER CORP.
K003796 12/08/2000 ADVIA 120 HEMATOLOGY BAYER CORP.
K993711 11/03/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) BAYER CORP.
K991576 05/06/1999 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP.
K971989 05/29/1997 TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K971998 05/30/1997 ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM BAYER CORP.
K992136 06/24/1999 BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) BAYER CORP.
K972462 07/01/1997 AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K992228 07/02/1999 BAYER IMMUNO 1 HER-2/NEU ASSAY BAYER CORP.
K972580 07/10/1997 DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K992662 08/09/1999 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP.
K982802 08/10/1998 BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K954332 09/18/1995 RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K973616 09/23/1997 TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K954594 10/03/1995 RETICULOCYTE METHOD, RBC INDICES BAYER CORP.
K954607 10/04/1995 RETICULOCYTE METHOD BAYER CORP.
K993867 11/15/1999 BAYER ADVIA IMS SYSTEM BAYER CORP.
K983345 09/23/1998 BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY BAYER CORP.
K993353 10/05/1999 TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K991817 05/27/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP.
K982328 07/02/1998 BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K974721 12/18/1997 UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K955760 12/20/1995 TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM BAYER CORP.
K991907 06/07/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP.
K980521 01/28/1998 DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS BAYER CORP.
K980376 01/30/1998 THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K990346 02/04/1999 BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP.
K951359 03/27/1995 RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE BAYER CORP.
K961351 04/05/1996 HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD BAYER CORP.
K981312 04/10/1998 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K961412 04/12/1996 CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO BAYER CORP.
K971716 05/09/1997 PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K971713 05/09/1997 N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K962125 06/03/1996 TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K962344 06/18/1996 MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K962355 06/18/1996 FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K982714 08/04/1998 BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY BAYER CORP.
K963080 08/08/1996 TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K964068 10/10/1996 CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K964098 10/11/1996 CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K964116 10/15/1996 QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K983715 10/21/1998 THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K964442 11/06/1996 VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K955087 11/07/1995 HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS BAYER CORP.
K964587 11/15/1996 VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K964703 11/22/1996 THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K964791 11/29/1996 B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K992399 07/19/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP.
K990649 03/01/1999 GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS BAYER CORP.
K991242 04/12/1999 GLUCOMETER ELITE TEST STRIPS BAYER CORP.
K991315 04/19/1999 MICROALBUSTIX REAGENT STRIPS (OTC) BAYER CORP.
K012205 07/16/2001 GLUCOMETER DEX TEST SENSOR BAYER CORP.
K984006 11/10/1998 GLUCOMETER ELITE XL BLOOD GLUCOSE METER BAYER CORP.
K024062 12/09/2002 ASCENSIA BREEZE BLOOD GLUCOSE METER BAYER CORP.
K024234 12/23/2002 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL BAYER CORP.
K023584 10/25/2002 ASCENSIA DEX 2 DIABETES CARE SYSTEM BAYER CORP.
K020828 03/14/2002 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER CORP.
K021428 05/03/2002 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM BAYER CORP.
K011963 06/22/2001 ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY BAYER CORP.
K022288 07/15/2002 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER CORP.
K012340 07/24/2001 BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) BAYER CORP.
K012337 07/24/2001 BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM BAYER CORP.
K012777 08/20/2001 ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS BAYER CORP.
K013272 10/01/2001 ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY BAYER CORP.
K013568 10/26/2001 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER CORP.
K024017 12/04/2002 BAYER ADVIA CENTAUR HER-2/NEU ASSAY BAYER CORP.
K960546 02/08/1996 CLINITEK 50 URINE CHEMISTRY ANALYZER BAYER CORP.
K960888 03/04/1996 CHEK-STIX U.T.I. SELF-TEST BAYER CORP.
K971276 04/07/1997 GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER BAYER CORP.
K982219 06/24/1998 MICROALBUSTIX REAGENT STRIPS BAYER CORP.
K972706 07/21/1997 CLINITEK MICROALBUMIN REAGENT STRIPS BAYER CORP.
K964630 11/19/1996 GLUCOMETER ELITE BLOOD GLUCOSE METER BAYER CORP.
K963142 08/13/1996 DCA 2000 + MICROALBUMIN/CREATININE ASSAY BAYER CORP.
K963500 09/03/1996 GLUCOMETER DEX DIABETES CARE SYSTEM BAYER CORP.
K964004 10/07/1996 GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS BAYER CORP.
K971209 04/02/1997 CLINITEK HCG TEST STRIPS BAYER CORP.
K992257 07/06/1999 NEW MULTIPLES REAGENT STRIPS BAYER CORP.
K020806 03/12/2002 ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY BAYER CORP.
K993571 10/21/1999 BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 BAYER CORP.
K023944 11/26/2002 BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST BAYER CORP.
K010668 03/06/2001 BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY BAYER CORP.
K010755 03/13/2001 BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY BAYER CORP.
K002376 08/04/2000 ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY BAYER CORP.
K002738 09/01/2000 BAYER RAPIDPOINT 400 SYSTEM BAYER CORP.
K993309 10/04/1999 BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY BAYER CORP.
K003412 11/02/2000 ADVIA CENTAUR RUBELLA IGG ASSAY BAYER CORP.
K994221 12/15/1999 BAYER PSA ASSAY BAYER CORP.


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