510(k) K772084

LAS-R HUMAN C3 PROACTIVATOR TEST by Hyland Therapeutic Div., Travenol Laboratories — Product Code JZH

K772084 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "LAS-R HUMAN C3 PROACTIVATOR TEST". The FDA issued a decision of Substantially Equivalent on January 24, 1978. The device falls under product code JZH (Factor B, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5320. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.