Trace Scientific , Ltd. - FDA 510(k) Cleared Devices
55
Total
55
Cleared
0
Denied
51 devices
Cleared
Aug 19, 1987
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
Chemistry
203d
Cleared
Aug 19, 1987
MAGNESIUM REAGENT - CALMAGITE METHOD
Chemistry
203d
Cleared
Aug 19, 1987
TOTAL PROTEIN REAGENT - BIURET METHOD
Chemistry
203d
Cleared
Aug 19, 1987
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
Chemistry
203d
Cleared
Aug 19, 1987
MODIFIED ALT (GPT) REAGENT
Chemistry
56d
Cleared
Aug 19, 1987
MODIFIED ENZYMATIC BUN REAGENT
Chemistry
56d
Cleared
May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
Chemistry
22d
Cleared
May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
Chemistry
22d
Cleared
Feb 06, 1987
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
Chemistry
95d
Cleared
Feb 06, 1987
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)
Chemistry
95d
Cleared
Feb 06, 1987
LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE
Chemistry
95d
Cleared
Jan 21, 1987
AMYLASE REAGENT
Chemistry
79d
Cleared
Apr 24, 1986
ALP (ALKALINE PHOSPHATASE) REAGENT
Chemistry
57d
Cleared
Apr 24, 1986
ENZYMATIC BUN REAGENT
Chemistry
57d
Cleared
Apr 24, 1986
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE
Chemistry
57d
Cleared
Apr 21, 1986
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
Chemistry
54d
Cleared
Apr 16, 1986
ENZYMATIC URIC ACID REAGENT
Chemistry
49d
Cleared
Apr 11, 1986
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)
Chemistry
44d
Cleared
Apr 07, 1986
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
Chemistry
40d
Cleared
Apr 07, 1986
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE)
Chemistry
40d
Cleared
Apr 07, 1986
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
Chemistry
40d
Cleared
Apr 07, 1986
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT
Chemistry
40d
Cleared
Apr 07, 1986
L D H-L (LACTIC DEHYDROGENASE) REAGENT
Chemistry
40d
Cleared
Apr 07, 1986
LDH-P (LACTIC DEHYDROGENASE) REAGENT
Chemistry
40d
Cleared
Apr 07, 1986
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL)
Chemistry
40d