Bayer Corp

FDA Filings

This page includes the latest FDA filings for Bayer Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
BAYER CORP.
ASCENSIA BREEZE BLOOD GLUCOSE METER2003-03-03
BAYER CORP.
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST2003-02-11
BAYER CORP.
BAYER ADVIA CENTAUR HER-2/NEU ASSAY2003-01-30
BAYER CORP.
ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL2003-01-23
BAYER CORP.
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM2002-12-17
BAYER CORP.
ASCENSIA DEX 2 DIABETES CARE SYSTEM2002-11-20
BAYER CORP.
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM2002-07-24
BAYER CORP.
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM2002-07-05
BAYER CORP.
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY2002-03-27
BAYER CORP.
BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM2001-12-06
BAYER CORP.
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY2001-11-20
BAYER CORP.
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY2001-10-25
BAYER CORP.
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS2001-10-22
BAYER CORP.
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)2001-10-01
BAYER CORP.
GLUCOMETER DEX TEST SENSOR2001-09-12
BAYER CORP.
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY2001-08-20
BAYER CORP.
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY2001-07-05
BAYER CORP.
ADVIA CENTAUR RUBELLA IGG ASSAY2001-04-13
BAYER CORP.
BAYER ADVIA IMS SYSTEM2001-03-29
BAYER CORP.
ADVIA 120 HEMATOLOGY2001-02-05
BAYER CORP.
BAYER RAPIDPOINT 400 SYSTEM2000-12-19
BAYER CORP.
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY2000-10-26
BAYER CORP.
BAYER IMMUNO 1 HER-2/NEU ASSAY2000-09-29
BAYER CORP.
ADVIA IMS2000-06-26
BAYER CORP.
BAYER ADVIA IMS SYSTEM; 200 + 32000-05-18
BAYER CORP.
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM2000-05-18
BAYER CORP.
BAYER PSA ASSAY2000-04-13
BAYER CORP.
BAYER ADVIA IMS SYSTEM2000-04-10
BAYER CORP.
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM2000-02-15
BAYER CORP.
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)1999-12-16
BAYER CORP.
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB121999-12-16
BAYER CORP.
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)1999-12-06
BAYER CORP.
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY1999-12-06
BAYER CORP.
NEW MULTIPLES REAGENT STRIPS1999-11-24
BAYER CORP.
MICROALBUSTIX REAGENT STRIPS (OTC)1999-11-12
BAYER CORP.
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)1999-11-09
BAYER CORP.
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM1999-11-09
BAYER CORP.
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM1999-09-15
BAYER CORP.
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM1999-07-22
BAYER CORP.
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS1999-07-09
BAYER CORP.
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM1999-06-30
BAYER CORP.
GLUCOMETER ELITE TEST STRIPS1999-06-30
BAYER CORP.
BAYER ADVIA 1650 CHEMISTRY SYSTEM1999-05-21
BAYER CORP.
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1999-05-14
BAYER CORP.
GLUCOMETER ELITE XL BLOOD GLUCOSE METER1999-03-18
BAYER CORP.
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1999-01-29
BAYER CORP.
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY1998-12-07
BAYER CORP.
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY1998-10-22
BAYER CORP.
BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1998-09-22
BAYER CORP.
MICROALBUSTIX REAGENT STRIPS1998-08-12
BAYER CORP.
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1998-06-05
BAYER CORP.
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1998-04-23
BAYER CORP.
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS1998-04-02
BAYER CORP.
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1998-03-03
BAYER CORP.
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1997-12-05
BAYER CORP.
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1997-12-01
BAYER CORP.
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM1997-10-31
BAYER CORP.
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1997-10-22
BAYER CORP.
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1997-09-22
BAYER CORP.
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1997-09-22
BAYER CORP.
CLINITEK MICROALBUMIN REAGENT STRIPS1997-09-09
BAYER CORP.
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM1997-08-29
BAYER CORP.
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1997-06-27
BAYER CORP.
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER1997-06-16
BAYER CORP.
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1997-06-11
BAYER CORP.
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)1997-05-29
BAYER CORP.
CLINITEK HCG TEST STRIPS1997-04-04
BAYER CORP.
GLUCOMETER ELITE BLOOD GLUCOSE METER1997-02-10
BAYER CORP.
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS1997-02-10
BAYER CORP.
GLUCOMETER DEX DIABETES CARE SYSTEM1997-01-21
BAYER CORP.
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM1997-01-13

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
201810101152Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyALUMINUM FOIL HS:7607.20.50.00 INVOICE NO. 756598 DELIVERY NOTE NO. 6060066 PKG

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