Medical Device Manufacturer · US , Elkhart , IN

Bayer Corp. - FDA 510(k) Cleared Devices

96 submissions · 96 cleared · Since 1989
96
Total
96
Cleared
0
Denied
96 devices
76-96 of 96
Cleared Sep 27, 1996
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC...
K963080 · CDZ
Chemistry · 50d
Cleared Sep 27, 1996
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
K963142 · JIR
Chemistry · 45d
Cleared Aug 30, 1996
RETICULOCYTE METHOD
K954607 · GKL
Hematology · 331d
Cleared Aug 23, 1996
RETICULOCYTE METHOD, RBC INDICES
K954594 · GKZ
Hematology · 325d
Cleared Aug 15, 1996
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K962344 · DDR
Immunology · 58d
Cleared Aug 02, 1996
TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
K955760 · LGD
Microbiology · 226d
Cleared Aug 02, 1996
TECHNICON IMMUNO 1 SYSTEM
K962125 · JJE
Chemistry · 60d
Cleared Jul 12, 1996
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO...
K962355 · CDP
Chemistry · 24d
Cleared Jul 05, 1996
CHEK-STIX U.T.I. SELF-TEST
K960888 · JMT
Chemistry · 123d
Cleared Jun 18, 1996
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
K961412 · JHY
Toxicology · 67d
Cleared Jun 13, 1996
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS...
K955087 · LCP
Hematology · 219d
Cleared Jun 12, 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546 · KQO
Chemistry · 125d
Cleared Jun 03, 1996
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL...
K961351 · DHA
Chemistry · 59d
Cleared Apr 15, 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359 · LFX
Microbiology · 385d
Cleared Jan 24, 1996
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K954332 · CGN
Chemistry · 128d
Cleared Nov 13, 1995
QUINTEST
K953939 · SCL
General Hospital · 90d
Cleared Jul 14, 1995
GLUCOMETER ELITE M BLOOD GLUCOSE METER
K951537 · CGA
Chemistry · 102d
Cleared Jun 13, 1995
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM
K952075 · JLS
Chemistry · 41d
Cleared Jun 09, 1995
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K951631 · LFM
Chemistry · 63d
Cleared May 02, 1995
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K951360 · CHP
Chemistry · 36d
Cleared Jun 16, 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117 · CGA
Chemistry · 52d

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