Roche Diagnostics Corp. · Class I · Cleared Nov 15, 2001
| K-number | K013278 |
| Device name | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 |
| Applicant | Roche Diagnostics Corp. |
| Product code | DEL |
| Device class | Class I |
| Decision date | Nov 15, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 866.5590 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov