Medical Device Manufacturer · US , Mchenry , IL

Pointe Scientific, Inc., - FDA 510(k) Cleared Devices

74 submissions · 74 cleared · Since 1981

74

Total

74

Cleared

0

Denied

69 devices

26-50 of 69

Cleared Nov 18, 1996

TOTAL IRON (NITRO-PAPS) REAGENT SET

Chemistry · 208d

Cleared Jun 03, 1996

LACTATE DEHYDROGENASE REAGENT SET

Chemistry · 49d

Cleared Aug 01, 1994

LIQUID AMYLASE (CNPG3) REAGENT SET

Chemistry · 165d

Cleared May 03, 1994

LIQUID ALT(SGPT) REAGENT SET

Chemistry · 47d

Cleared May 02, 1994

LIQUID AST (SGOT)REAGENT SET

Chemistry · 54d

Cleared Jan 11, 1994

CREATINE KINASE-MB (CK-MB) REAGENT SET

Chemistry · 60d

Cleared Jul 19, 1993

LIQUID AMYLASE REAGENT SET

Chemistry · 172d

Cleared Mar 29, 1993

CREATINE KINASE (CK) REAGENT SET

Chemistry · 48d

Cleared May 13, 1992

CALCIUM-ARSENAZO III REAGENT SET

Chemistry · 37d

Cleared Dec 04, 1991

DIAZO COLORIMETRY, BILIRUBIN

Chemistry · 36d

Cleared Apr 30, 1991

Chemistry · 105d

Cleared Feb 23, 1990

CARBON DIOXIDE REAGENT

Chemistry · 81d

Cleared Feb 01, 1990

CARBON DIOXIDE REAGENT

Chemistry · 72d

Cleared Apr 10, 1989

HDL CHOLESTEROL REAGENT

Chemistry · 39d

Cleared Dec 04, 1987

CRESOLPHTHALEIN COMPLEXONE, CALCIUM

Chemistry · 52d

Cleared Jan 21, 1987

PSI AMYLASE REAGENT

Chemistry · 70d

Cleared Jan 21, 1987

FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY

Chemistry · 40d

Cleared Dec 16, 1986

NAPHTHYL PHOSPHATE, ACID PHOSPHATASE

Chemistry · 77d

Cleared Jul 22, 1986

Chemistry · 55d

Cleared Feb 21, 1986

DIRECT BILIRUBIN

Chemistry · 28d

Cleared Sep 16, 1985

Chemistry · 20d

Cleared Aug 21, 1985

CHLORIDE REAGENT

Chemistry · 93d

Cleared Nov 25, 1983

Chemistry · 95d

Cleared Oct 14, 1983

LIPASE HYDROLYSIS/GLYCEROL KINASE

Chemistry · 50d

Cleared Oct 14, 1983

HEXOKINASE, GLUCOSE

Chemistry · 50d