| Record ID | K843438 |
|---|---|
| Device Name | FACTOR XI DEFICIENT PLASMA B11D |
| Applicant | Sigma Chemical Co. |
| Product Code | GGP · Hematology |
| Decision Date | Nov 19, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7290 |
| Device Class | Class 2 |
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