Precision Biologic · Class II · Cleared Mar 18, 1999
| K-number | K990296 |
| Device name | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) |
| Applicant | Precision Biologic |
| Product code | GJT |
| Device class | Class II |
| Decision date | Mar 18, 1999 |
| Decision | Substantially Equivalent |
| Regulation | 864.7290 |
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