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."
25–48 of 55
Search insights Median review: 57d Cleared: 100% Top manufacturer: Trace Scientific , Ltd. Lead specialty: Chemistry
Cleared Aug 19, 1987
MODIFIED ENZYMATIC BUN REAGENT
K872484 · CDQ
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Aug 19, 1987
MODIFIED ALT (GPT) REAGENT
K872483 · CKA
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Aug 19, 1987
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
K870372 · CIX
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
TOTAL PROTEIN REAGENT - BIURET METHOD
K870371 · CEK
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
MAGNESIUM REAGENT - CALMAGITE METHOD
K870370 · JGJ
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
K870369 · CIA
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION
K870368 · CEO
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
CREATININE REAGENT - PICRIC ACID METHOD
K870366 · CGX
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD
K870365 · CIG
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
TOTAL BILIRUBIN REAGENT - DMSO METHOD
K870364 · CIG
Trace Scientific , Ltd.
Chemistry · 203d
Cleared May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
K871509 · CDT
Trace Scientific , Ltd.
Chemistry · 22d
Cleared May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
K871508 · CDT
Trace Scientific , Ltd.
Chemistry · 22d
Cleared Mar 16, 1987
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
K870363 · KHG
Trace Scientific , Ltd.
Hematology · 47d
Cleared Feb 06, 1987
LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE
K864360
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Feb 06, 1987
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)
K864359 · CGS
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Feb 06, 1987
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K864357 · CIT
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Jan 21, 1987
AMYLASE REAGENT
K864356 · CIJ
Trace Scientific , Ltd.
Chemistry · 79d
Cleared Apr 24, 1986
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE
K860733 · CGS
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
ENZYMATIC BUN REAGENT
K860716 · CDQ
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
ALP (ALKALINE PHOSPHATASE) REAGENT
K860715 · CJE
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 21, 1986
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
K860726 · LFR
Trace Scientific , Ltd.
Chemistry · 54d
Cleared Apr 16, 1986
ENZYMATIC URIC ACID REAGENT
K860732 · KNK
Trace Scientific , Ltd.
Chemistry · 49d
Cleared Apr 11, 1986
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)
K860717 · CHH
Trace Scientific , Ltd.
Chemistry · 44d
Cleared Apr 07, 1986
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)
K860731 · JGY
Trace Scientific , Ltd.
Chemistry · 40d