K251440
- 510(k) number
- K251440
- Device name
- CRYOcheck Chromogenic Factor VIII
- Applicant
- Precision Biologic, Inc. CA
- Product code
- GGP — Test, Qualitative And Quantitative Factor Deficiency
- Decision date
- 2025-08-25
- Date received
- 2025-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251440.pdf
Official FDA record: K251440
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.