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FDA 510(k)

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

K-Number: K190485 · 2019-07-08

ApplicantKawasumi Laboratories, Inc.
Decision Date2019-07-08
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 Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K190485. 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 2019-07-08. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K190485.

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 2019-07-08, under 510(k) number K190485.

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

The FDA 510(k) record lists 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 Kawasumi Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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