Device type
Platelet Factor 4 Radioimmunoassay
Product code LCO · Class II · 21 CFR 864.7695 · Hematology
Recent 510(k)s
No 510(k) clearances in the archive for LCO.
Recent recalls
Oct 21, 2026
Z-0001-2027
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Instrumentation Laboratory
- LCO
- Class I
- Ongoing
Oct 21, 2026
Z-0002-2027
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Instrumentation Laboratory
- LCO
- Class I
- Ongoing