Trace America, Inc.

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K003583	LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901	NDW	2001-01-17	View
510(k)	K980026	GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	CFR	1998-03-10	View
510(k)	K980028	ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	CKA	1998-02-02	View
510(k)	K980030	AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	CIT	1998-01-30	View
510(k)	K973869	TRACE REAGENT LINE FOR THE COBAS MIRA	CKA	1998-01-07	View
510(k)	K974620	AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)	JIF	1998-01-02	View
510(k)	K972297	AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	JFJ	1997-07-17	View
510(k)	K971477	UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)	CDQ	1997-05-27	View
510(k)	K971485	URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	CDO	1997-05-27	View
510(k)	K962723	TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN	LBR	1997-03-13	View
510(k)	K961984	PORPHOBILINOGEN (PBG)	JNF	1996-12-10	View
510(k)	K961477	TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY	CDT	1996-08-05	View
510(k)	K960035	CARBON DIOXIDE - DST	KHS	1996-04-08	View
510(k)	K953971	TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY	CDT	1996-04-05	View
510(k)	K952410	CARBON DIOXIDE - DST	KHS	1995-10-05	View
510(k)	K925794	TRACE MICROPROTEIN REAGENT	JGQ	1993-03-29	View
510(k)	K920603	TRACE MAGNESIUM - ARSENAZO REAGENT	JGJ	1992-03-11	View
510(k)	K895381	HDL SINGLES	LBR	1989-11-08	View
510(k)	K880796	ALKALINE PHOSPHATASE REAGENT, DEA BUFF	CJE	1988-04-18	View
510(k)	K880798	ACID PHOSPHATASE REAGENT	CKB	1988-04-18	View