510(k) K071255

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A by Hyphen Biomed — Product Code LCO

K071255 is an FDA 510(k) premarket notification submitted by Hyphen Biomed for the device "ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A". The FDA issued a decision of Substantially Equivalent on September 7, 2007. The device falls under product code LCO (Platelet Factor 4 Radioimmunoassay), a Class II device regulated under 21 CFR 864.7695. Hyphen Biomed has at least 5 other 510(k) clearances on record.