Trace Scientific , Ltd.

FDA 510(k) & PMA Approved Devices — 55 products

Total Devices55

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K982121	ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT	DBM	1998-09-17	View
510(k)	K981123	UREA	CDQ	1998-04-24	View
510(k)	K962890	CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)	CHH	1996-09-27	View
510(k)	K961114	AST INCORPORATING DST	CIT	1996-05-23	View
510(k)	K961123	ALT INCORPORATING DST	CKA	1996-04-25	View
510(k)	K952488	TRACE COBAS MIRA RANGE	CIX	1995-10-13	View
510(k)	K932713	TRACE TRANSFERRIN REAGENT	DDQ	1993-09-30	View
510(k)	K923322	TRACE ALBUMIN-MR REAGENT	CIX	1992-09-11	View
510(k)	K914731	TRACE GAMMA GT-SS REAGENT	JQB	1991-11-19	View
510(k)	K911866	TRACE TOTAL/DIRECT BILIRUBIN REAGENT	CIG	1991-07-17	View
510(k)	K903897	TRIGLYCERIDES REAGENT GPO 5 X CONC.	CDT	1990-10-01	View
510(k)	K904116	IRON 5 X CONC REAGENT	JMO	1990-09-27	View
510(k)	K902678	LIQUID STABLE CHOLESTEROL REAGENT KIT	CHH	1990-09-25	View
510(k)	K903896	CALCIUM ARSENAZO III REAGENT	CIC	1990-09-13	View
510(k)	K891468	AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT	CIT	1989-05-22	View
510(k)	K891470	CK-NAC 2-VIAL REAGENT W/SUBSTRATE START	CGS	1989-05-09	View
510(k)	K890996	LD1 ISOENZYME REAGENT KIT	JGF	1989-05-05	View
510(k)	K891469	ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT	CKA	1989-04-04	View
510(k)	K890070	TOTAL BILIRUBIN REAGENT, CONCENTRATED	CIG	1989-03-06	View
510(k)	K881938	BICARBONATE (CO2) REAGENT-2 VIAL	KHS	1988-06-15	View