FDA 510(k) Applications Submitted by KENNETH EDDS

FDA 510(k) Number Submission Date Device Name Applicant
K972170 06/09/1997 ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION R & D SYSTEMS, INC.
K003874 12/15/2000 CBC-4K HEMATOLOGY CONTROL R & D SYSTEMS, INC.
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
K020217 01/22/2002 ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY BAYER DIAGNOSTICS CORP.
K030452 02/11/2003 BAYER LIGAND PLUS 1, 2, 3 CONTROLS BAYER DIAGNOSTICS CORP.
K010409 02/12/2001 CBC-SF R & D SYSTEMS, INC.
K010461 02/16/2001 ADVIA RETIC PLUS R & D SYSTEMS, INC.
K040425 02/18/2004 ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS BAYER HEALTHCARE, LLC
K010470 02/20/2001 R & D 4K RETIC R & D SYSTEMS, INC.
K020792 03/11/2002 ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP.
K020794 03/11/2002 SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP.
K020807 03/12/2002 AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP.
K020828 03/14/2002 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER CORP.
K031038 04/01/2003 ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY BAYER HEALTHCARE, LLC
K021151 04/10/2002 AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP.
K031393 05/02/2003 BAYER ADVIA CENTAUR CA 19-9 ASSAY BAYER HEALTHCARE, LLC
K021428 05/03/2002 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM BAYER CORP.
K021532 05/10/2002 ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR BAYER DIAGNOSTICS CORP.
K021535 05/10/2002 ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR BAYER DIAGNOSTICS CORP.
K031683 05/30/2003 TOX AMMONIA CALIBRATOR BAYER HEALTHCARE, LLC
K031682 05/30/2003 LIPOPROTEIN CALIBRATOR BAYER HEALTHCARE, LLC
K011963 06/22/2001 ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY BAYER CORP.
K982231 06/25/1998 STATUSFLOW R & D SYSTEMS, INC.
K022096 06/27/2002 URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP.
K022177 07/03/2002 PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP.
K022178 07/03/2002 CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP.
K022288 07/15/2002 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER CORP.
K022329 07/18/2002 CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP.
K022331 07/18/2002 ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD BAYER DIAGNOSTICS CORP.
K012337 07/24/2001 BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM BAYER CORP.
K012340 07/24/2001 BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) BAYER CORP.
K012357 07/25/2001 CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER DIAGNOSTICS CORP.
K022668 08/12/2002 ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD BAYER DIAGNOSTICS CORP.
K032524 08/15/2003 ADVIA 60 HEMATOLOGY ANALYZER BAYER HEALTHCARE, LLC
K012777 08/20/2001 ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS BAYER CORP.
K012904 08/29/2001 ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION BAYER DIAGNOSTICS CORP.
K022968 09/06/2002 ADVIA TESTPOINT CSF CONTROL BAYER DIAGNOSTICS CORP.
K023184 09/24/2002 ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP.
K033007 09/26/2003 BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP.
K013272 10/01/2001 ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY BAYER CORP.
K993321 10/04/1999 R&D HGB/GLC WHOLE BLOOD CONTROL R & D SYSTEMS, INC.
K003208 10/13/2000 R & D 3K RETIC R & D SYSTEMS, INC.
K013406 10/15/2001 ADVIA CENTAUR HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP.
K013568 10/26/2001 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER CORP.
K013606 10/31/2001 ACS 180 HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP.
K013750 11/13/2001 ADVIA 1650 CHOLINESTERASE ASSAY BAYER DIAGNOSTICS CORP.
K003534 11/16/2000 PENTRA 5D R & D SYSTEMS, INC.
K984099 11/17/1998 QBC CENTRIFUGAL HEMATOLOGY CONTROL R & D SYSTEMS, INC.
K964767 11/27/1996 QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( R & D SYSTEMS, INC.
K013959 11/30/2001 BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS BAYER DIAGNOSTICS CORP.
K024017 12/04/2002 BAYER ADVIA CENTAUR HER-2/NEU ASSAY BAYER CORP.
K003991 12/26/2000 CD-CAL PLUS CALIBRATOR R & D SYSTEMS, INC.
K970718 02/26/1997 QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) R & D SYSTEMS, INC.
K961610 04/25/1996 R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) R & D SYSTEMS, INC.
K033643 11/20/2003 CO2 CALIBRATOR/DILUENT BAYER HEALTHCARE, DIAGNOSTICS DIVISION


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