510(k) K251995— Access anti-HAV IgM

Substantially Equivalent

Beckman Coulter, Inc.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LOL
Advisory panel: Microbiology
Date received: 2025-06-27
Decision date: 2026-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.