510(k) K810835

RUBAZYME - M by Abbott Laboratories — Product Code GOK

K810835 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "RUBAZYME - M". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code GOK (Antisera, Hai (Including Hai Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Abbott Laboratories has at least 10 other 510(k) clearances on record.