510(k) K223810

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) by Sb-Kawasumi Laboratories, Inc. — Product Code JKA

K223810 is an FDA 510(k) premarket notification submitted by Sb-Kawasumi Laboratories, Inc. for the device "Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)". The FDA issued a decision of Substantially Equivalent on February 24, 2023. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sb-Kawasumi Laboratories, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2023
Date Received
December 20, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type