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 a medical device manufactured by Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2016-06-07 under approval 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. It is manufactured by Beckman Coulter Ireland, Inc.. The 510(k) number is K161297.
When was Beta-2-Microglobulin approved by the FDA?
Beta-2-Microglobulin received FDA 510(k) clearance on 2016-06-07, under approval number K161297.
What company makes Beta-2-Microglobulin?
Beta-2-Microglobulin is manufactured by Beckman Coulter Ireland, Inc..
What is the FDA product code for Beta-2-Microglobulin?
The FDA product code for Beta-2-Microglobulin is JZG.
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.