Trace America, Inc. - FDA 510(k) Cleared Devices
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Trace America, Inc. Chemistry ✕
22 devices
Cleared
Jan 17, 2001
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
Chemistry
58d
Cleared
Mar 10, 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Chemistry
64d
Cleared
Feb 02, 1998
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
Chemistry
28d
Cleared
Jan 30, 1998
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
Chemistry
25d
Cleared
Jan 07, 1998
TRACE REAGENT LINE FOR THE COBAS MIRA
Chemistry
105d
Cleared
Jan 02, 1998
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Chemistry
22d
Cleared
Jul 17, 1997
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Chemistry
28d
Cleared
May 27, 1997
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Chemistry
34d
Cleared
May 27, 1997
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Chemistry
34d
Cleared
Mar 13, 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
Chemistry
241d
Cleared
Dec 10, 1996
PORPHOBILINOGEN (PBG)
Chemistry
203d
Cleared
Aug 05, 1996
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
Chemistry
109d
Cleared
Apr 08, 1996
CARBON DIOXIDE - DST
Chemistry
96d
Cleared
Apr 05, 1996
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY
Chemistry
226d
Cleared
Oct 05, 1995
CARBON DIOXIDE - DST
Chemistry
134d
Cleared
Mar 29, 1993
TRACE MICROPROTEIN REAGENT
Chemistry
133d
Cleared
Mar 11, 1992
TRACE MAGNESIUM - ARSENAZO REAGENT
Chemistry
39d
Cleared
Nov 08, 1989
HDL SINGLES
Chemistry
71d
Cleared
Apr 18, 1988
RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
Chemistry
52d
Cleared
Apr 18, 1988
RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.
Chemistry
52d
Cleared
Apr 18, 1988
ALKALINE PHOSPHATASE REAGENT, DEA BUFF
Chemistry
52d
Cleared
Apr 18, 1988
ACID PHOSPHATASE REAGENT
Chemistry
52d