MDA D-DIMER
Device Facts
| Record ID | K000492 |
|---|---|
| Device Name | MDA D-DIMER |
| Applicant | Organon Teknika Corp. |
| Product Code | DAP · Hematology |
| Decision Date | Jun 7, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
| Record ID | K000492 |
|---|---|
| Device Name | MDA D-DIMER |
| Applicant | Organon Teknika Corp. |
| Product Code | DAP · Hematology |
| Decision Date | Jun 7, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
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