Access EPO
K-Number: K240182 · 2024-04-22
ApplicantBeckman Coulter, Inc.
Decision Date2024-04-22
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Access EPO is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-04-22 under approval number K240182. The device is classified under product code GGT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Access EPO?
Access EPO is a medical device that received FDA 510(k) clearance on 2024-04-22. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K240182.
When was Access EPO approved by the FDA?
Access EPO received FDA 510(k) clearance on 2024-04-22, under approval number K240182.
What company makes Access EPO?
Access EPO is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access EPO?
The FDA product code for Access EPO is GGT.
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Related Devices (Code: GGT)
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.