| Record ID | K834050 |
|---|---|
| Device Name | PROTOPATH FACTOR IX ASSAY |
| Applicant | American Dade |
| Product Code | GGP · Hematology |
| Decision Date | Feb 4, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7290 |
| Device Class | Class 2 |
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