The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Trace Albumin-mr Reagent.
| Device ID | K923322 |
| 510k Number | K923322 |
| Device Name: | TRACE ALBUMIN-MR REAGENT |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | Peter Murphy |
| Correspondent | Peter Murphy TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-07 |
| Decision Date | 1992-09-11 |