Company ยท US
Trace America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2001. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 |
| LBR | Ldl & Vldl Precipitation, Hdl | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JGQ | Turbidimetric, Total Protein | 1 |
| JIF | Enzymatic Method, Ammonia | 1 |
| JNF | Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen | 1 |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 2001 | K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 Trace America, Inc. | NDW |
| Mar 10, 1998 | K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. | CFR |
| Feb 2, 1998 | K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. | CKA |
| Jan 30, 1998 | K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. | CIT |
| Jan 7, 1998 | K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA Trace America, Inc. | CKA |
| Jan 2, 1998 | K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) Trace America, Inc. | JIF |
| Jul 17, 1997 | K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. | JFJ |
| May 27, 1997 | K971485 | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. | CDO |
| May 27, 1997 | K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) Trace America, Inc. | CDQ |
| Mar 13, 1997 | K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN Trace America, Inc. | LBR |
| Dec 10, 1996 | K961984 | PORPHOBILINOGEN (PBG) Trace America, Inc. | JNF |
| Aug 5, 1996 | K961477 | TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY Trace America, Inc. | CDT |
| Apr 8, 1996 | K960035 | CARBON DIOXIDE - DST Trace America, Inc. | KHS |
| Apr 5, 1996 | K953971 | TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY Trace America, Inc. | CDT |
| Oct 5, 1995 | K952410 | CARBON DIOXIDE - DST Trace America, Inc. | KHS |
| Mar 29, 1993 | K925794 | TRACE MICROPROTEIN REAGENT Trace America, Inc. | JGQ |
| Mar 11, 1992 | K920603 | TRACE MAGNESIUM - ARSENAZO REAGENT Trace America, Inc. | JGJ |
| Nov 8, 1989 | K895381 | HDL SINGLES Trace America, Inc. | LBR |
| Apr 18, 1988 | K880798 | ACID PHOSPHATASE REAGENT Trace America, Inc. | CKB |
| Apr 18, 1988 | K880796 | ALKALINE PHOSPHATASE REAGENT, DEA BUFF Trace America, Inc. | CJE |
| Apr 18, 1988 | K880795 | RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. Trace America, Inc. | CJE |
| Apr 18, 1988 | K880794 | RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL Trace America, Inc. | KHS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||