| Record ID | K002642 |
|---|---|
| Device Name | MINIQUANT D-DIMER, MODEL 1447 |
| Applicant | Biopool Intl., Inc. |
| Product Code | DAP · Hematology |
| Decision Date | Feb 5, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
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