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

Cleared Jul 12, 1985

HEMOGLOBIN

K851432 · KHG

Hematology · 93d

Cleared Nov 25, 1983

AMYLASE

K832889 · JFJ

Chemistry · 95d

Cleared Oct 14, 1983

LIPASE HYDROLYSIS/GLYCEROL KINASE

K832871 · CDT

Chemistry · 50d

Cleared Oct 14, 1983

HEXOKINASE, GLUCOSE

K832872 · CFR

Chemistry · 50d

Cleared Sep 26, 1983

DIAZO COLORIMETRY, BILLIRUBIN

K832870 · CIG

Chemistry · 32d

Cleared Mar 24, 1983

CREATININE

K830556 · CGX

Chemistry · 29d

Cleared Sep 14, 1982

PSI TOTAL PROTEIN REAGENT

K822468 · CEK

Chemistry · 28d

Cleared Sep 14, 1982

PSI CALCIUM REAGENT

K822469 · CIC

Chemistry · 28d

Cleared Sep 14, 1982

PSI INORGANIC PHOSPHORUS

K822470 · CEO

Chemistry · 28d

Cleared Sep 14, 1982

PSI ALBUMIN REAGENT

K822471 · CIX

Chemistry · 28d

Cleared Dec 31, 1981

ALT (SGPT)

K813495 · CKA

Chemistry · 17d

Cleared Dec 31, 1981

LDH-L

K813496 · CFJ

Chemistry · 17d

Cleared Dec 22, 1981

AST(SGOT) IN VITRO DIAG. REAGENT SET

K813405 · CIT

Chemistry · 15d

Cleared Dec 22, 1981

CPK(CK) IN VITRO DIAG. REAGENT SET

K813406 · JHS

Chemistry · 15d

Cleared Oct 20, 1981

LIPASE

K812794 · CET

Chemistry · 14d

Cleared Oct 06, 1981

AMYLASE

K812699 · KHM

Chemistry · 14d

Cleared Sep 24, 1981

HDL CHOLESTEROL REAGENT

K812574 · LBR

Chemistry · 15d

Cleared Sep 09, 1981

URIC ACID REAGENT SET

K812430 · KNK

Chemistry · 15d

Cleared Sep 09, 1981

ALKALINE PHOSPHATASE

K812452 · CJE

Chemistry · 12d

Cleared Sep 01, 1981

UREA NITROGEN (BUN)

K812341 · CDQ

Chemistry · 14d

Cleared Aug 31, 1981

GAMMA GLUTAMY TRANSPEPTIDASE

K812296 · JQB

Chemistry · 17d

Cleared Mar 31, 1981

ENZYMATIC CHOLESTEROL

K810673 · CHH

Chemistry · 19d

Cleared Mar 31, 1981

GLUCOSE OXIDASE

K810674 · CGA

Toxicology · 19d

Cleared Mar 31, 1981

ENZYMATIC TRIGLYCERIDE

K810680 · CDT

Chemistry · 18d