The following data is part of a premarket notification filed by Precision Biologic with the FDA for Cryocheck Prekallikrein Deficient Plalsma, Model Fdpk10/10 (10 X 1.0 Ml), Fdpk10/25 (25 X 1.0ml).
| Device ID | K990296 |
| 510k Number | K990296 |
| Device Name: | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Contact | Sandy Morrison |
| Correspondent | Sandy Morrison PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-28 |
| Decision Date | 1999-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000381 | K990296 | 000 |