Elecsys AFP— 510(k) K220176

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K220176 for Elecsys AFP, Substantially Equivalent on 2022-09-15. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LOJ
Advisory panel: Immunology
Date received: 2022-01-21
Decision date: 2022-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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