Cleared Traditional

Access anti-HAV

K243846 · Beckman Coulter, Inc. · Microbiology
Sep 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K243846 is an FDA 510(k) clearance for the Access anti-HAV, a Hepatitis A Test (antibody And Igm Antibody) (Class II — Special Controls, product code LOL), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 9, 2025, 267 days after receiving the submission on December 16, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K243846 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2024
Decision Date September 09, 2025
Days to Decision 267 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