GKP
- Product code
- GKP
- Device name
- Instrument, Coagulation, Automated
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.5400
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 49
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242127 | 2024-08-16 | Instrumentation Laboratory (IL) Co. | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 C | FDA |
Official FDA classification page: GKP
Classification and pathway per current FDA publications. Data from openFDA (CC0).