ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
Device Facts
| Record ID | K002706 |
|---|---|
| Device Name | ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI |
| Applicant | Roche Diagnostics Corp. |
| Product Code | DAP · Hematology |
| Decision Date | Mar 16, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
