Cleared Traditional

MONOLISA ANTI-HAV IGM EIA

K092353 · Bio-Rad Laboratories, Inc. · Microbiology
Oct 2009
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K092353 is an FDA 510(k) clearance for the MONOLISA ANTI-HAV IGM EIA, a Hepatitis A Test (antibody And Igm Antibody) (Class II — Special Controls, product code LOL), submitted by Bio-Rad Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on October 29, 2009, 86 days after receiving the submission on August 4, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K092353 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2009
Decision Date October 29, 2009
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LOL — Hepatitis A Test (antibody And Igm Antibody)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3310