Medical Device Manufacturer · US , Mchenry , IL

Smithkline Diagnostics, Inc. - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1976

42

Total

42

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smithkline Diagnostics, Inc. Chemistry ✕

22 devices

1-12 of 22

Cleared Mar 01, 1988

(SKD) CHOLESTEROL TEST KIT

Chemistry · 77d

Cleared Mar 05, 1986

SKD ELECTROCHEMICAL SYSTEM (ECS)

Chemistry · 103d

Cleared May 24, 1982

SPIN CHEM REAGENTS & STANDARDS

Chemistry · 27d

Cleared May 14, 1982

TARGET ISOCHECK CONTROL SERUM

Chemistry · 17d

Cleared Sep 14, 1981

SPIN-CHEM TRIGLYCERIDES REAGENT

Chemistry · 14d

Cleared Sep 14, 1981

SPIN-CHEM LD-L REAGENT

Chemistry · 14d

Cleared Jul 23, 1981

ESKAFLOW TEST FOR TRIGLYCERIDES

Chemistry · 22d

Cleared Jul 15, 1981

ESKAFLOW TEST FOR GLUCOSE

Chemistry · 14d

Cleared Feb 26, 1981

ESKACHEM PAP REAGENT

Chemistry · 66d

Cleared Oct 30, 1979

ESKACHEM, CK-MB REAGENT

Chemistry · 21d

Cleared Jul 24, 1979

PLUS CHEM S.C.E. REAGENT

Chemistry · 42d

Cleared Jul 17, 1979

SPIN CHEM REAGENT, DETERMINATION OF LDH-

Chemistry · 35d