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Bayer Diagnostics Corp.

32 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
BAYER SPECIAL CHEMISTRY CONTROLS (K033379)Bayer Diagnostics Corp.2003-12-19
BAYER SPECIAL CHEMISTRY CALIBRATORS (K033380)Bayer Diagnostics Corp.2003-12-16
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (K033007)Bayer Diagnostics Corp.2003-11-14
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (K031857)Bayer Diagnostics Corp.2003-09-04
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022096)Bayer Diagnostics Corp.2003-03-18
BAYER LIGAND PLUS 1, 2, 3 CONTROLS (K030452)Bayer Diagnostics Corp.2003-03-03
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (K023840)Bayer Diagnostics Corp.2003-01-07
AMMONIA ASSAY FOR THE ADVIA 1650 (K023841)Bayer Diagnostics Corp.2002-12-24
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022177)Bayer Diagnostics Corp.2002-12-17
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022329)Bayer Diagnostics Corp.2002-11-27
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K023184)Bayer Diagnostics Corp.2002-11-18
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022178)Bayer Diagnostics Corp.2002-11-12
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD (K022668)Bayer Diagnostics Corp.2002-10-15
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020807)Bayer Diagnostics Corp.2002-10-01
ADVIA TESTPOINT CSF CONTROL (K022968)Bayer Diagnostics Corp.2002-09-24
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (K022331)Bayer Diagnostics Corp.2002-09-11
BAYER RAPIDPOINT 405 SYSTEM (K020616)Bayer Diagnostics Corp.2002-07-17
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K021151)Bayer Diagnostics Corp.2002-07-13
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020794)Bayer Diagnostics Corp.2002-07-11
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020792)Bayer Diagnostics Corp.2002-07-11
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR (K021535)Bayer Diagnostics Corp.2002-06-27
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR (K021532)Bayer Diagnostics Corp.2002-06-27
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY (K020217)Bayer Diagnostics Corp.2002-03-15
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K012357)Bayer Diagnostics Corp.2002-02-28
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS (K013959)Bayer Diagnostics Corp.2002-01-29
ADVIA 1650 CHOLINESTERASE ASSAY (K013750)Bayer Diagnostics Corp.2002-01-18
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY (K012183)Bayer Diagnostics Corp.2001-12-27
ACS 180 HOMOCYSTEINE ASSAY (K013606)Bayer Diagnostics Corp.2001-12-21
ADVIA CENTAUR HOMOCYSTEINE ASSAY (K013406)Bayer Diagnostics Corp.2001-12-18
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION (K012904)Bayer Diagnostics Corp.2001-09-21
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY (K010050)Bayer Diagnostics Corp.2001-02-05
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY (K003291)Bayer Diagnostics Corp.2000-12-05

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Every clearance here is in the API, with alerts when new ones post.