510(k) K170854

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

K170854 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls". The FDA issued a decision of Substantially Equivalent on September 8, 2017. 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.