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FDA 510(k)

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

K-Number: K223810 · 2023-02-24

ApplicantSb-Kawasumi Laboratories, Inc.
Decision Date2023-02-24
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K223810. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)?

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K223810.

When did Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) receive FDA 510(k) clearance?

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) received FDA 510(k) clearance on 2023-02-24, under 510(k) number K223810.

Who is the listed applicant for Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)?

The FDA 510(k) record lists Sb-Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)?

The FDA product code for Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is JKA.

Other records listing Sb-Kawasumi Laboratories, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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