Access EPO— 510(k) K240182

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K240182 for Access EPO, Substantially Equivalent on 2024-04-22. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GGT
Advisory panel: Hematology
Date received: 2024-01-23
Decision date: 2024-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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