510(k) K153137

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls by Instrumentation Laboratory CO — Product Code LCO

K153137 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls". The FDA issued a decision of Substantially Equivalent on July 8, 2016. The device falls under product code LCO (Platelet Factor 4 Radioimmunoassay), a Class II device regulated under 21 CFR 864.7695. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.