Access AMH— 510(k) K223679

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K223679 for Access AMH, Substantially Equivalent on 2023-02-03. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code PQO
Advisory panel: Clinical Chemistry
Date received: 2022-12-08
Decision date: 2023-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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