GGW
- Product code
- GGW
- Device name
- Test, Time, Partial Thromboplastin
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.7925
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 32
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260551 | 2026-03-20 | Instrumentation Laboratory (IL) Co. | HemosIL Factor V Leiden (APC Resistance V) |
Official FDA classification page: GGW
Classification and pathway per current FDA publications. Data from openFDA (CC0).