Access Folate Assay
K-Number: K223590 · 2023-08-23
ApplicantBeckman Coulter, Inc.
Decision Date2023-08-23
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Access Folate Assay is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-08-23 under approval number K223590. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Access Folate Assay?
Access Folate Assay is a medical device that received FDA 510(k) clearance on 2023-08-23. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K223590.
When was Access Folate Assay approved by the FDA?
Access Folate Assay received FDA 510(k) clearance on 2023-08-23, under approval number K223590.
What company makes Access Folate Assay?
Access Folate Assay is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access Folate Assay?
The FDA product code for Access Folate Assay is CGN.
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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.