Access Testosterone— 510(k) K223405

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K223405 for Access Testosterone, Substantially Equivalent on 2023-01-13. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 2022-11-09
Decision date: 2023-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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