Access anti-HBc IgM— 510(k) K254059

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K254059 for Access anti-HBc IgM, Substantially Equivalent on 2026-03-13. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code SEI
Advisory panel: Microbiology
Date received: 2025-12-17
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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