ANTI-HAV— 510(k) K100903

Substantially Equivalent

Roche Professional Diagnostics

FDA 510(k) clearance K100903 for ANTI-HAV, Substantially Equivalent on 2010-10-05. Applicant: Roche Professional Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Professional Diagnostics
Product code: Code LOL
Device class: Class 2
Regulation: 21 CFR 866.3310
Advisory panel: Microbiology
Date received: 2010-04-01
Decision date: 2010-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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