Access anti-HAV— 510(k) K243846

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K243846 for Access anti-HAV, Substantially Equivalent on 2025-09-09. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LOL
Advisory panel: Microbiology
Date received: 2024-12-16
Decision date: 2025-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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