Trace America, Inc.
Medical device manufacturer in Arlington, TX.
22510(k) clearances
0PMA approvals
0recalls
Device types
- KHS Enzymatic, Carbon-Dioxide 3
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 2
- LBR Ldl & Vldl Precipitation, Hdl 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 2
- CKB Acid Phosphatase, Naphthyl Phosphate 1
- JGJ Photometric Method, Magnesium 1
- JGQ Turbidimetric, Total Protein 1
- JNF Ion-Exchange Resin, Ehrlich'S Reagent… 1
- CDQ Urease And Glutamic Dehydrogenase, Urea… 1
- CDO Acid, Uric, Uricase (U.V.) 1
- JFJ Catalytic Methods, Amylase 1
- JIF Enzymatic Method, Ammonia 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CFR Hexokinase, Glucose 1
- NDW Assay, Porphyrin, Spectrophotometry, Lithium 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K003583 | Lithium Regent Model TR66056 / Lithium Standard TR66901NDW · Traditional | 01/17/2001SE |
| K980026 | Glucose (HK) - Incorporating Dynamic Stabilization Technology - (DST)CFR · Traditional | 03/10/1998SE |
| K980028 | Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional | 02/02/1998SE |
| K980030 | Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CIT · Traditional | 01/30/1998SE |
| K973869 | Trace Reagent Line for the Cobas MiraCKA · Traditional | 01/07/1998SE |
| K974620 | Ammonia-Incorporating Dynamic Stabilization Technology (DST)JIF · Traditional | 01/02/1998SE |
| K972297 | Amylase-Incorporating Dynamic Stabilization Technology - (DST)JFJ · Traditional | 07/17/1997SE |
| K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)CDO · Traditional | 05/27/1997SE |
| K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)CDQ · Traditional | 05/27/1997SE |
| K962723 | Trace HDL Cholesterol - Automated (HomogenLBR · Traditional | 03/13/1997SE |
| K961984 | Porphobilinogen (PBG)JNF · Traditional | 12/10/1996SE |
| K961477 | Triglycerides - Incorporating Dynamic Stabilization TechnologyCDT · Traditional | 08/05/1996SE |
| K960035 | Carbon Dioxide - DSTKHS · Traditional | 04/08/1996SE |
| K953971 | Triglycerides Liquid Stable Incorporating Dynamic Stabilisation TechnologyCDT · Traditional | 04/05/1996SE |
| K952410 | Carbon Dioxide - DSTKHS · Traditional | 10/05/1995SE |
| K925794 | Trace Microprotein ReagentJGQ · Traditional | 03/29/1993SE |
| K920603 | Trace Magnesium - Arsenazo ReagentJGJ · Traditional | 03/11/1992SE |
| K895381 | HDL SinglesLBR · Traditional | 11/08/1989SE |
| K880798 | Acid Phosphatase ReagentCKB · Traditional | 04/18/1988SE |
| K880796 | Alkaline Phosphatase Reagent, Dea BuffCJE · Traditional | 04/18/1988SE |
| K880795 | Resubmitted Alkaline Phosphatase Reagent Amp Buff.CJE · Traditional | 04/18/1988SE |
| K880794 | Resubmitted Bicarbonate (CO2) Reagent Single VialKHS · Traditional | 04/18/1988SE |