Cleared Traditional

LIAISON HAV IgM, LIAISON Control HAV IgM

K160650 · DiaSorin, Inc. · Microbiology
Aug 2016
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K160650 is an FDA 510(k) clearance for the LIAISON HAV IgM, LIAISON Control HAV IgM, a Hepatitis A Test (antibody And Igm Antibody) (Class II — Special Controls, product code LOL), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on August 25, 2016, 170 days after receiving the submission on March 8, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K160650 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2016
Decision Date August 25, 2016
Days to Decision 170 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