CRYOcheck Factor VIII Deficient Plasma with VWF — Precision Biologic, Inc. (510(k) K222831)
CRYOcheck Factor VIII Deficient Plasma with VWF — Precision Biologic, Inc. (510(k) K222831) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: CRYOcheck Factor VIII Deficient Plasma with VWF; Applicant: Precision Biologic, Inc.; Clearance track: 510(k).
| Device name | CRYOcheck Factor VIII Deficient Plasma with VWF |
|---|---|
| Applicant | Precision Biologic, Inc. |
| Clearance track | 510(k) |
| Submission number | K222831 |
| Decision | Substantially Equivalent |
| Decision date | 2023-09-13 |
| Date received | 2022-09-19 |
| Product code | GJT |
| Device class | 2 |
| Medical specialty | Hematology |
| Applicant location | CA |
| Source | openFDA device |
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