Access Cortisol
K-Number: K223038 · 2023-02-08
ApplicantBeckman Coulter, Inc.
Decision Date2023-02-08
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Access Cortisol is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-02-08 under approval number K223038. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Access Cortisol?
Access Cortisol is a medical device that received FDA 510(k) clearance on 2023-02-08. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K223038.
When was Access Cortisol approved by the FDA?
Access Cortisol received FDA 510(k) clearance on 2023-02-08, under approval number K223038.
What company makes Access Cortisol?
Access Cortisol is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access Cortisol?
The FDA product code for Access Cortisol is CGR.
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Related Devices (Code: CGR)
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.