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Trace Scientific , Ltd.

55 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (K982121)Trace Scientific , Ltd.1998-09-17
UREA (K981123)Trace Scientific , Ltd.1998-04-24
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (K962890)Trace Scientific , Ltd.1996-09-27
AST INCORPORATING DST (K961114)Trace Scientific , Ltd.1996-05-23
ALT INCORPORATING DST (K961123)Trace Scientific , Ltd.1996-04-25
TRACE COBAS MIRA RANGE (K952488)Trace Scientific , Ltd.1995-10-13
TRACE TRANSFERRIN REAGENT (K932713)Trace Scientific , Ltd.1993-09-30
TRACE ALBUMIN-MR REAGENT (K923322)Trace Scientific , Ltd.1992-09-11
TRACE GAMMA GT-SS REAGENT (K914731)Trace Scientific , Ltd.1991-11-19
TRACE TOTAL/DIRECT BILIRUBIN REAGENT (K911866)Trace Scientific , Ltd.1991-07-17
TRIGLYCERIDES REAGENT GPO 5 X CONC. (K903897)Trace Scientific , Ltd.1990-10-01
IRON 5 X CONC REAGENT (K904116)Trace Scientific , Ltd.1990-09-27
LIQUID STABLE CHOLESTEROL REAGENT KIT (K902678)Trace Scientific , Ltd.1990-09-25
CALCIUM ARSENAZO III REAGENT (K903896)Trace Scientific , Ltd.1990-09-13
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT (K891468)Trace Scientific , Ltd.1989-05-22
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START (K891470)Trace Scientific , Ltd.1989-05-09
LD1 ISOENZYME REAGENT KIT (K890996)Trace Scientific , Ltd.1989-05-05
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT (K891469)Trace Scientific , Ltd.1989-04-04
TOTAL BILIRUBIN REAGENT, CONCENTRATED (K890070)Trace Scientific , Ltd.1989-03-06
BICARBONATE (CO2) REAGENT-2 VIAL (K881938)Trace Scientific , Ltd.1988-06-15
HDL CHOLESTEROL KIT (K881244)Trace Scientific , Ltd.1988-06-10
IRON REAGENT (K874055)Trace Scientific , Ltd.1987-10-28
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD (K870362)Trace Scientific , Ltd.1987-08-21
CHLORIDE REAGENT - THIOCYANATE METHOD (K870367)Trace Scientific , Ltd.1987-08-21
MODIFIED ENZYMATIC BUN REAGENT (K872484)Trace Scientific , Ltd.1987-08-19
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD (K870372)Trace Scientific , Ltd.1987-08-19
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD (K870369)Trace Scientific , Ltd.1987-08-19
MODIFIED ALT (GPT) REAGENT (K872483)Trace Scientific , Ltd.1987-08-19
PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION (K870368)Trace Scientific , Ltd.1987-08-19
CREATININE REAGENT - PICRIC ACID METHOD (K870366)Trace Scientific , Ltd.1987-08-19
TOTAL PROTEIN REAGENT - BIURET METHOD (K870371)Trace Scientific , Ltd.1987-08-19
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD (K870365)Trace Scientific , Ltd.1987-08-19
MAGNESIUM REAGENT - CALMAGITE METHOD (K870370)Trace Scientific , Ltd.1987-08-19
TOTAL BILIRUBIN REAGENT - DMSO METHOD (K870364)Trace Scientific , Ltd.1987-08-19
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL (K871508)Trace Scientific , Ltd.1987-05-08
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) (K871509)Trace Scientific , Ltd.1987-05-08
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD (K870363)Trace Scientific , Ltd.1987-03-16
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) (K864359)Trace Scientific , Ltd.1987-02-06
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT (K864357)Trace Scientific , Ltd.1987-02-06
LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE (K864360)Trace Scientific , Ltd.1987-02-06
AMYLASE REAGENT (K864356)Trace Scientific , Ltd.1987-01-21
ENZYMATIC BUN REAGENT (K860716)Trace Scientific , Ltd.1986-04-24
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE (K860733)Trace Scientific , Ltd.1986-04-24
ALP (ALKALINE PHOSPHATASE) REAGENT (K860715)Trace Scientific , Ltd.1986-04-24
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID (K860726)Trace Scientific , Ltd.1986-04-21
ENZYMATIC URIC ACID REAGENT (K860732)Trace Scientific , Ltd.1986-04-16
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) (K860717)Trace Scientific , Ltd.1986-04-11
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT (K860727)Trace Scientific , Ltd.1986-04-07
L D H-L (LACTIC DEHYDROGENASE) REAGENT (K860728)Trace Scientific , Ltd.1986-04-07
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) (K860724)Trace Scientific , Ltd.1986-04-07
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT (K860725)Trace Scientific , Ltd.1986-04-07
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT (K860723)Trace Scientific , Ltd.1986-04-07
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) (K860730)Trace Scientific , Ltd.1986-04-07
LDH-P (LACTIC DEHYDROGENASE) REAGENT (K860729)Trace Scientific , Ltd.1986-04-07
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) (K860731)Trace Scientific , Ltd.1986-04-07

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Every clearance here is in the API, with alerts when new ones post.