510(k) K230408

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) by Sb-Kawasumi Laboratories, Inc. — Product Code JKA

K230408 is an FDA 510(k) premarket notification submitted by Sb-Kawasumi Laboratories, Inc. for the device "K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)". The FDA issued a decision of Substantially Equivalent on June 1, 2023. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sb-Kawasumi Laboratories, Inc. has at least 4 other 510(k) clearances on record.