K222831 is an FDA 510(k) clearance for the CRYOcheck Factor VIII Deficient Plasma with VWF. This device is classified as a Plasma, Coagulation Factor Deficient (Class II - Special Controls, product code GJT).
Submitted by Precision Biologic, Inc. (Darmouth, CA). The FDA issued a Cleared decision on September 13, 2023, 359 days after receiving the submission on September 19, 2022.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K222831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2022 |
| Decision Date | September 13, 2023 |
| Days to Decision | 359 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJT - Plasma, Coagulation Factor Deficient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |