| Record ID | K942049 |
|---|---|
| Device Name | BIOMERIEUX HEMOLAB COFAC II |
| Applicant | Biomerieux Vitek, Inc. |
| Product Code | GJT · Hematology |
| Decision Date | May 19, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7290 |
| Device Class | Class 2 |
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