K251995

Substantially Equivalent

Access anti-HAV IgM

Applicant: Beckman Coulter, Inc.
Product 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.