GGP
- Product code
- GGP
- Device name
- Test, Qualitative And Quantitative Factor Deficiency
- 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)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 190 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251440 | 2025-08-25 | Precision Biologic, Inc. | CRYOcheck Chromogenic Factor VIII | |
| K230852 | 2023-12-13 | Instrumentation Laboratory Company | HemosIL Chromogenic Factor IX |
Official FDA classification page: GGP
Classification and pathway per current FDA publications. Data from openFDA (CC0).