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FDA 510(k)

Ceruloplasmin

K-Number: K161508 · 2017-01-09

ApplicantBeckman Coulter Ireland, Inc.
Decision Date2017-01-09
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Ceruloplasmin 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 2017-01-09 under 510(k) number K161508. The device is classified under product code DDB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceruloplasmin?

Ceruloplasmin is a medical device that received FDA 510(k) clearance on 2017-01-09. The listed applicant is Beckman Coulter Ireland, Inc.. The 510(k) number is K161508.

When did Ceruloplasmin receive FDA 510(k) clearance?

Ceruloplasmin received FDA 510(k) clearance on 2017-01-09, under 510(k) number K161508.

Who is the listed applicant for Ceruloplasmin?

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 Ceruloplasmin?

The FDA product code for Ceruloplasmin is DDB.

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

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