Access CEA
K-Number: K223921 · 2023-09-22
ApplicantBeckman Coulter, Inc.
Decision Date2023-09-22
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Access CEA is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-09-22 under approval number K223921. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Access CEA?
Access CEA is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K223921.
When was Access CEA approved by the FDA?
Access CEA received FDA 510(k) clearance on 2023-09-22, under approval number K223921.
What company makes Access CEA?
Access CEA is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access CEA?
The FDA product code for Access CEA is DHX.
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Related Devices (Code: DHX)
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.