Access Rubella IgG— 510(k) K250588

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K250588 for Access Rubella IgG, Substantially Equivalent on 2025-11-17. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LFX
Advisory panel: Microbiology
Date received: 2025-02-27
Decision date: 2025-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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