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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K223810
Device Name Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
Applicant
Sb-Kawasumi Laboratories, Inc.
3-25-4 Tonomachi, Kawasaki-Ku
Kawasaki-Shi,  JP 210-8602
Applicant Contact Shiro Agehama
Correspondent
Regulatory Compliance Associates, Inc. (Rca)
10411 Corporate Dr.
Suite 102
Pleasant Prarie,  WI  53158
Correspondent Contact Valerie Followell
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/20/2022
Decision Date 02/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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