Elecsys Anti-HAV II— 510(k) K190428

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K190428 for Elecsys Anti-HAV II, Substantially Equivalent on 2019-08-13. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LOL
Advisory panel: Microbiology
Date received: 2019-02-22
Decision date: 2019-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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