510(k) K781629

SERI-SEP SERUM/PLASMA ISLOLATOR by Wako Intl., Inc. — Product Code JKA

K781629 is an FDA 510(k) premarket notification submitted by Wako Intl., Inc. for the device "SERI-SEP SERUM/PLASMA ISLOLATOR". The FDA issued a decision of Substantially Equivalent on October 27, 1978. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Wako Intl., Inc. has at least 3 other 510(k) clearances on record.