510(k) K840212

CONCENTRATED PLATELET ADMIN. SET by American Mcgaw — Product Code FPA

K840212 is an FDA 510(k) premarket notification submitted by American Mcgaw for the device "CONCENTRATED PLATELET ADMIN. SET". The FDA issued a decision of Substantially Equivalent on March 6, 1984. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. American Mcgaw has at least 10 other 510(k) clearances on record.