| Record ID | K861973 |
|---|---|
| Device Name | D-DI TEST KIT |
| Applicant | American Bioproducts Co. |
| Product Code | GHH · Hematology |
| Decision Date | Sep 4, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
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