Cleared Traditional

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

K230408 · Sb-Kawasumi Laboratories, Inc. · General Hospital
Jun 2023
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K230408 is an FDA 510(k) clearance for the K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM), a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Sb-Kawasumi Laboratories, Inc. (Kanagawa, JP). The FDA issued a Cleared decision on June 1, 2023, 106 days after receiving the submission on February 15, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K230408 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2023
Decision Date June 01, 2023
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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