510(k) K941159

DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G by International Technidyne Corp. — Product Code JKA

K941159 is an FDA 510(k) premarket notification submitted by International Technidyne Corp. for the device "DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G". The FDA issued a decision of Substantially Equivalent on May 19, 1994. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. International Technidyne Corp. has at least 10 other 510(k) clearances on record.