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 a medical device manufactured by Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2017-01-09 under approval 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. It is manufactured by Beckman Coulter Ireland, Inc.. The 510(k) number is K161508.
When was Ceruloplasmin approved by the FDA?
Ceruloplasmin received FDA 510(k) clearance on 2017-01-09, under approval number K161508.
What company makes Ceruloplasmin?
Ceruloplasmin is manufactured by Beckman Coulter Ireland, Inc..
What is the FDA product code for Ceruloplasmin?
The FDA product code for Ceruloplasmin is DDB.
Other Devices by Beckman Coulter Ireland, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.