Elecsys AMH— 510(k) K203757

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K203757 for Elecsys AMH, Substantially Equivalent on 2022-06-10. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code PQO
Advisory panel: Clinical Chemistry
Date received: 2020-12-23
Decision date: 2022-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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