The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Trace Microprotein Reagent.
| Device ID | K925794 |
| 510k Number | K925794 |
| Device Name: | TRACE MICROPROTEIN REAGENT |
| Classification | Turbidimetric, Total Protein |
| Applicant | TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | JGQ |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1993-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275003239 | K925794 | 000 |