FDA 510(k) Applications Submitted by TRACE AMERICA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K971485 |
04/23/1997 |
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K974620 |
12/11/1997 |
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) |
TRACE AMERICA, INC. |
| K960035 |
01/03/1996 |
CARBON DIOXIDE - DST |
TRACE AMERICA, INC. |
| K980026 |
01/05/1998 |
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K980028 |
01/05/1998 |
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K980030 |
01/05/1998 |
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K961477 |
04/18/1996 |
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY |
TRACE AMERICA, INC. |
| K971477 |
04/23/1997 |
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) |
TRACE AMERICA, INC. |
| K961984 |
05/21/1996 |
PORPHOBILINOGEN (PBG) |
TRACE AMERICA, INC. |
| K972297 |
06/19/1997 |
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K962723 |
07/15/1996 |
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN |
TRACE AMERICA, INC. |
| K953971 |
08/23/1995 |
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY |
TRACE AMERICA, INC. |
| K973869 |
09/24/1997 |
TRACE REAGENT LINE FOR THE COBAS MIRA |
TRACE AMERICA, INC. |
| K003583 |
11/20/2000 |
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 |
TRACE AMERICA, INC. |
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