Access Myoglobin— 510(k) K231832

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K231832 for Access Myoglobin, Substantially Equivalent on 2023-09-18. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DDR
Advisory panel: Immunology
Date received: 2023-06-22
Decision date: 2023-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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