CRYOcheck Factor VIII Deficient Plasma with VWF— 510(k) K222831
Substantially EquivalentPrecision Biologic, Inc.
FDA 510(k) clearance K222831 for CRYOcheck Factor VIII Deficient Plasma with VWF, Substantially Equivalent on 2023-09-13. Applicant: Precision Biologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Precision Biologic, Inc.
- Product code
- Code GJT
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Darmouth, CA
Recent devices under product code GJT
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