LCO
- Product code
- LCO
- Device name
- Platelet Factor 4 Radioimmunoassay
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.7695
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 13 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243374 | 2025-01-28 | Instrumentation Laboratory (IL) Co. | HemosIL CL HIT-IgG(PF4-H) |
Official FDA classification page: LCO
Classification and pathway per current FDA publications. Data from openFDA (CC0).