Trace Scientific , Ltd. - FDA 510(k) Cleared Devices

Cleared Apr 24, 1998

UREA

K981123 · CDQ

Chemistry · 28d

Cleared Sep 27, 1996

CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)

K962890 · CHH

Chemistry · 65d

Cleared May 23, 1996

AST INCORPORATING DST

K961114 · CIT

Chemistry · 64d

Cleared Apr 25, 1996

ALT INCORPORATING DST

K961123 · CKA

Chemistry · 35d

Cleared Oct 13, 1995

TRACE COBAS MIRA RANGE

K952488 · CIX

Chemistry · 136d

Cleared Nov 19, 1991

TRACE GAMMA GT-SS REAGENT

K914731 · JQB

Chemistry · 29d

Cleared Jul 17, 1991

TRACE TOTAL/DIRECT BILIRUBIN REAGENT

K911866 · CIG

Chemistry · 82d

Cleared Oct 01, 1990

TRIGLYCERIDES REAGENT GPO 5 X CONC.

K903897 · CDT

Chemistry · 39d

Cleared Sep 27, 1990

IRON 5 X CONC REAGENT

K904116 · JMO

Chemistry · 21d

Cleared Sep 25, 1990

LIQUID STABLE CHOLESTEROL REAGENT KIT

K902678 · CHH

Chemistry · 98d

Cleared Sep 13, 1990

CALCIUM ARSENAZO III REAGENT

K903896 · CIC

Chemistry · 21d

Cleared May 22, 1989

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

K891468 · CIT

Chemistry · 68d