K222831
- 510(k) number
- K222831
- Device name
- CRYOcheck Factor VIII Deficient Plasma with VWF
- Applicant
- Precision Biologic, Inc. CA
- Product code
- GJT — Plasma, Coagulation Factor Deficient
- Decision date
- 2023-09-13
- Date received
- 2022-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K222831.pdf
Official FDA record: K222831
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.