| Record ID | K011143 |
|---|---|
| Device Name | TINA-QUANT D-DIMER TEST SYSTEM |
| Applicant | Roche Diagnostics Corp. |
| Product Code | GHH · Hematology |
| Decision Date | May 29, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
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