| Record ID | K945642 |
|---|---|
| Device Name | AGEN DIMERTEST GOLD EIA |
| Applicant | Agen Biomedical , Ltd. |
| Product Code | GHH · Hematology |
| Decision Date | Oct 25, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
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