BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
Device Facts
| Record ID | K905643 |
|---|---|
| Device Name | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY |
| Applicant | Agen Biomedical , Ltd. |
| Product Code | GHH · Hematology |
| Decision Date | Apr 12, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
