Trace America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901January 17, 2001
K980026GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)March 10, 1998
K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)February 2, 1998
K980030AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)January 30, 1998
K973869TRACE REAGENT LINE FOR THE COBAS MIRAJanuary 7, 1998
K974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)January 2, 1998
K972297AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)July 17, 1997
K971477UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)May 27, 1997
K971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)May 27, 1997
K962723TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGENMarch 13, 1997
K961984PORPHOBILINOGEN (PBG)December 10, 1996
K961477TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGYAugust 5, 1996
K960035CARBON DIOXIDE - DSTApril 8, 1996
K953971TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGYApril 5, 1996
K952410CARBON DIOXIDE - DSTOctober 5, 1995
K925794TRACE MICROPROTEIN REAGENTMarch 29, 1993
K920603TRACE MAGNESIUM - ARSENAZO REAGENTMarch 11, 1992
K895381HDL SINGLESNovember 8, 1989
K880798ACID PHOSPHATASE REAGENTApril 18, 1988
K880795RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.April 18, 1988