FDA 510(k) Applications Submitted by SB-Kawasumi Laboratories, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K230408 02/15/2023 K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) SB-Kawasumi Laboratories, Inc.
K220799 03/18/2022 K-SHIELD Zen SB-Kawasumi Laboratories, Inc.
K223810 12/20/2022 Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) SB-Kawasumi Laboratories, Inc.


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