Cleared Special

LIAISON Anti-HAV

K210272 · DiaSorin, Inc. · Microbiology
Feb 2021
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K210272 is an FDA 510(k) clearance for the LIAISON Anti-HAV, 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 February 9, 2021, 8 days after receiving the submission on February 1, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K210272 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2021
Decision Date February 09, 2021
Days to Decision 8 days
Submission Type Special
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