Roche Diagnostics Corp. · Class II · Cleared Nov 13, 2001
| K-number | K013207 |
| Device name | TINA-QUANT APOLIPOPROTEIN B VER.2 |
| Applicant | Roche Diagnostics Corp. |
| Product code | DFC |
| Device class | Class II |
| Decision date | Nov 13, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 866.5600 |
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