The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Trace Cobas Mira Range.
| Device ID | K952488 |
| 510k Number | K952488 |
| Device Name: | TRACE COBAS MIRA RANGE |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | CIX |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CHJ |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CKA |
| Subsequent Product Code | JFJ |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JGY |
| Subsequent Product Code | JLP |
| Subsequent Product Code | JQB |
| Subsequent Product Code | KHS |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-30 |
| Decision Date | 1995-10-13 |