GJT
- Product code
- GJT
- Device name
- Plasma, Coagulation Factor Deficient
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.7290
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 79
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K222831 | 2023-09-13 | Precision Biologic, Inc. | CRYOcheck Factor VIII Deficient Plasma with VWF |
Official FDA classification page: GJT
Classification and pathway per current FDA publications. Data from openFDA (CC0).