Cleared Special

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

K223810 · Sb-Kawasumi Laboratories, Inc. · General Hospital
Feb 2023
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K223810 is an FDA 510(k) clearance for the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH), a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Sb-Kawasumi Laboratories, Inc. (Kawasaki-Shi, JP). The FDA issued a Cleared decision on February 24, 2023, 66 days after receiving the submission on December 20, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K223810 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2022
Decision Date February 24, 2023
Days to Decision 66 days
Submission Type Special
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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