MONOLISA ANTI-HAV EIA— 510(k) K092355

Name: FDA 510(k) clearance K092355
Creator: U.S. Food and Drug Administration
Published: 2009-10-29

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K092355 for MONOLISA ANTI-HAV EIA, Substantially Equivalent on 2009-10-29. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code LOL
Device class: Class 2
Regulation: 21 CFR 866.3310
Advisory panel: Microbiology
Date received: 2009-08-04
Decision date: 2009-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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