Cleared Traditional

LIAISON Anti-HAV Assay

K193532 · DiaSorin, Inc. · Microbiology
Mar 2020
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K193532 is an FDA 510(k) clearance for the LIAISON Anti-HAV Assay, 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 March 2, 2020, 73 days after receiving the submission on December 20, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K193532 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2019
Decision Date March 02, 2020
Days to Decision 73 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