Access anti-HBc Total— 510(k) K253687

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K253687 for Access anti-HBc Total, Substantially Equivalent on 2026-02-19. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code SEI
Advisory panel: Microbiology
Date received: 2025-11-21
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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