Cleared Traditional

Access anti-HAV IgM

K251995 · Beckman Coulter, Inc. · Microbiology
Jan 2026
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K251995 is an FDA 510(k) clearance for the Access anti-HAV IgM, 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 January 27, 2026, 214 days after receiving the submission on June 27, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K251995 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date January 27, 2026
Days to Decision 214 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