| Record ID | K890189 |
|---|---|
| Device Name | AGEN DIMERTEST EIA |
| Applicant | Agen Biomedical , Ltd. |
| Product Code | DAP · Hematology |
| Decision Date | Mar 3, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
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