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FDA 510(k)

Access Testosterone

K-Number: K223405 · 2023-01-13

ApplicantBeckman Coulter, Inc.
Decision Date2023-01-13
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Testosterone is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-01-13 under approval number K223405. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Testosterone?

Access Testosterone is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K223405.

When was Access Testosterone approved by the FDA?

Access Testosterone received FDA 510(k) clearance on 2023-01-13, under approval number K223405.

What company makes Access Testosterone?

Access Testosterone is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access Testosterone?

The FDA product code for Access Testosterone is CDZ.

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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.

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