LCO

Platelet Factor 4 Radioimmunoassay

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)

Last three years. Most recent: 2025-01-28.

NumberDecision dateApplicantDevice nameSummary
K2433742025-01-28Instrumentation Laboratory (IL) Co.HemosIL CL HIT-IgG(PF4-H)PDF

1 summaries are archived here for direct download.

Official FDA classification page: LCO
Classification and pathway per current FDA publications. Data from openFDA (CC0).