Cleared Special

LIAISON Anti-HAV; LIAISON XS

K223403 · DiaSorin, Inc. · Microbiology
Dec 2022
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K223403 is an FDA 510(k) clearance for the LIAISON Anti-HAV; LIAISON XS, 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 December 9, 2022, 30 days after receiving the submission on November 9, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K223403 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2022
Decision Date December 09, 2022
Days to Decision 30 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