Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

55 results for "Trace Scientific , Ltd."
1–24 of 55
Search insights Median review: 57d Cleared: 100% Top manufacturer: Trace Scientific , Ltd. Lead specialty: Chemistry
Cleared Sep 17, 1998
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · DBM
Trace Scientific , Ltd.
Immunology · 93d
Cleared Apr 24, 1998
UREA
K981123 · CDQ
Trace Scientific , Ltd.
Chemistry · 28d
Cleared Sep 27, 1996
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890 · CHH
Trace Scientific , Ltd.
Chemistry · 65d
Cleared May 23, 1996
AST INCORPORATING DST
K961114 · CIT
Trace Scientific , Ltd.
Chemistry · 64d
Cleared Apr 25, 1996
ALT INCORPORATING DST
K961123 · CKA
Trace Scientific , Ltd.
Chemistry · 35d
Cleared Oct 13, 1995
TRACE COBAS MIRA RANGE
K952488 · CIX
Trace Scientific , Ltd.
Chemistry · 136d
Cleared Sep 30, 1993
TRACE TRANSFERRIN REAGENT
K932713 · DDQ
Trace Scientific , Ltd.
Hematology · 118d
Cleared Sep 11, 1992
TRACE ALBUMIN-MR REAGENT
K923322 · CIX
Trace Scientific , Ltd.
Hematology · 66d
Cleared Nov 19, 1991
TRACE GAMMA GT-SS REAGENT
K914731 · JQB
Trace Scientific , Ltd.
Chemistry · 29d
Cleared Jul 17, 1991
TRACE TOTAL/DIRECT BILIRUBIN REAGENT
K911866 · CIG
Trace Scientific , Ltd.
Chemistry · 82d
Cleared Oct 01, 1990
TRIGLYCERIDES REAGENT GPO 5 X CONC.
K903897 · CDT
Trace Scientific , Ltd.
Chemistry · 39d
Cleared Sep 27, 1990
IRON 5 X CONC REAGENT
K904116 · JMO
Trace Scientific , Ltd.
Chemistry · 21d
Cleared Sep 25, 1990
LIQUID STABLE CHOLESTEROL REAGENT KIT
K902678 · CHH
Trace Scientific , Ltd.
Chemistry · 98d
Cleared Sep 13, 1990
CALCIUM ARSENAZO III REAGENT
K903896 · CIC
Trace Scientific , Ltd.
Chemistry · 21d
Cleared May 22, 1989
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891468 · CIT
Trace Scientific , Ltd.
Chemistry · 68d
Cleared May 09, 1989
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
K891470 · CGS
Trace Scientific , Ltd.
Chemistry · 55d
Cleared May 05, 1989
LD1 ISOENZYME REAGENT KIT
K890996 · JGF
Trace Scientific , Ltd.
Chemistry · 67d
Cleared Apr 04, 1989
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891469 · CKA
Trace Scientific , Ltd.
Chemistry · 20d
Cleared Mar 06, 1989
TOTAL BILIRUBIN REAGENT, CONCENTRATED
K890070 · CIG
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Jun 15, 1988
BICARBONATE (CO2) REAGENT-2 VIAL
K881938 · KHS
Trace Scientific , Ltd.
Chemistry · 37d
Cleared Jun 10, 1988
HDL CHOLESTEROL KIT
K881244 · LBR
Trace Scientific , Ltd.
Chemistry · 79d
Cleared Oct 28, 1987
IRON REAGENT
K874055 · JMO
Trace Scientific , Ltd.
Chemistry · 23d
Cleared Aug 21, 1987
CHLORIDE REAGENT - THIOCYANATE METHOD
K870367 · CHJ
Trace Scientific , Ltd.
Chemistry · 205d
Cleared Aug 21, 1987
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
K870362 · CIC
Trace Scientific , Ltd.
Chemistry · 205d