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FDA 510(k)

Beta-2-Microglobulin

K-Number: K161297 · 2016-06-07

ApplicantBeckman Coulter Ireland, Inc.
Decision Date2016-06-07
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Beta-2-Microglobulin is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K161297. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Beta-2-Microglobulin?

Beta-2-Microglobulin is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Beckman Coulter Ireland, Inc.. The 510(k) number is K161297.

When did Beta-2-Microglobulin receive FDA 510(k) clearance?

Beta-2-Microglobulin received FDA 510(k) clearance on 2016-06-07, under 510(k) number K161297.

Who is the listed applicant for Beta-2-Microglobulin?

The FDA 510(k) record lists Beckman Coulter Ireland, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Beta-2-Microglobulin?

The FDA product code for Beta-2-Microglobulin is JZG.

Other records listing Beckman Coulter Ireland, 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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Official Source

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