Class Class II

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (K230408)

K230408 2023-06-01 Traditional
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Description

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) by Sb-Kawasumi Laboratories, Inc. — FDA 510(k) cleared clinical chemistry device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230408
Clearance Date2023-06-01
Clearance TypeTraditional
Product CodeJKA
Regulation Number862.1675

Categories

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