Access TPO Antibody— 510(k) K240469

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K240469 for Access TPO Antibody, Substantially Equivalent on 2024-08-09. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JZO
Advisory panel: Immunology
Date received: 2024-02-20
Decision date: 2024-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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