Medical Device Manufacturer · US , Mchenry , IL

Coulter Electronics, Inc. - FDA 510(k) Cleared Devices

101 submissions · 101 cleared · Since 1976

Recent clearances: CD8 CYTOSPHERES KIT, COULTER RETIC-C CELL CONTROL, CD4 CYTOSPHERES KIT

101

Total

101

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coulter Electronics, Inc. Chemistry ✕

43 devices

1-12 of 43

Cleared Feb 26, 1991

COULTER DART AST (GOT) REAGENT

Chemistry · 61d

Cleared Jan 25, 1991

COULTER DART ALT (GPT) REAGENT

Chemistry · 29d

Cleared Dec 26, 1990

COULTER DIRECT BILLRUBIN REAGENT

Chemistry · 12d

Cleared Dec 13, 1990

COULTER CK-MB ISOENZYME REAGENT

Chemistry · 45d

Cleared Mar 29, 1990

COULTER CHOLESTEROL REAGENT

Chemistry · 91d

Cleared Mar 09, 1990

COULTER TRIGLYCERIDES GPO REAGENT

Chemistry · 71d

Cleared Mar 09, 1990

COULTER GLUCOSE REAGENT

Chemistry · 71d

Cleared Mar 09, 1990

COULTER ALT (GPT) REAGENT

Chemistry · 71d

Cleared Mar 09, 1990

COULTER LD (LDH-L) REAGENT

Chemistry · 71d

Cleared Mar 01, 1990

COULTER URIC ACID REAGENT

Chemistry · 63d

Cleared Feb 23, 1990

COULTER AST (GOT) REAGENT

Chemistry · 57d

Cleared Feb 23, 1990

COULTER TOTAL PROTEIN REAGENT

Chemistry · 57d

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