Trace America, Inc.
Arlington, TX, US
Trace America, Inc. appears in FDA device records in Arlington, TX. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Trace America, Inc. between 1988 and 2001. The busiest year on record is 1998, with 5. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 4 |
| 1989 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 4 |
| 1997 | 4 |
| 1998 | 5 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | NDW | Substantially Equivalent | |
| K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CFR | Substantially Equivalent | |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CKA | Substantially Equivalent | |
| K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CIT | Substantially Equivalent | |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | CKA | Substantially Equivalent | |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | JIF | Substantially Equivalent | |
| K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | JFJ | Substantially Equivalent | |
| K971485 | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | CDO | Substantially Equivalent | |
| K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | CDQ | Substantially Equivalent | |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | LBR | Substantially Equivalent | |
| K961984 | PORPHOBILINOGEN (PBG) | JNF | Substantially Equivalent | |
| K961477 | TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY | CDT | Substantially Equivalent | |
| K960035 | CARBON DIOXIDE - DST | KHS | Substantially Equivalent | |
| K953971 | TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY | CDT | Substantially Equivalent | |
| K952410 | CARBON DIOXIDE - DST | KHS | Substantially Equivalent | |
| K925794 | TRACE MICROPROTEIN REAGENT | JGQ | Substantially Equivalent | |
| K920603 | TRACE MAGNESIUM - ARSENAZO REAGENT | JGJ | Substantially Equivalent | |
| K895381 | HDL SINGLES | LBR | Substantially Equivalent | |
| K880798 | ACID PHOSPHATASE REAGENT | CKB | Substantially Equivalent | |
| K880796 | ALKALINE PHOSPHATASE REAGENT, DEA BUFF | CJE | Substantially Equivalent | |
| K880795 | RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. | CJE | Substantially Equivalent | |
| K880794 | RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL | KHS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CDOAcid, Uric, Uricase (U.V.)
- NDWAssay, Porphyrin, Spectrophotometry, Lithium
- JFJCatalytic Methods, Amylase
- JIFEnzymatic Method, Ammonia
- KHSEnzymatic, Carbon-Dioxide
- CFRHexokinase, Glucose
- JNFIon-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JGJPhotometric Method, Magnesium
- JGQTurbidimetric, Total Protein
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain