The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Cryo-check Pnp Platelet Lysate, Model Pnp-10.
| Device ID | K982062 |
| 510k Number | K982062 |
| Device Name: | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 Dartmouth, Nova Scotia, CA B3b 1p7 |
| Contact | Sandy Morrison |
| Correspondent | Sandy Morrison PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 Dartmouth, Nova Scotia, CA B3b 1p7 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-15 |
| Decision Date | 1999-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000435 | K982062 | 000 |