Access Thyroglobulin Antibody II— 510(k) K213517

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K213517 for Access Thyroglobulin Antibody II, Substantially Equivalent on 2023-09-26. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JZO
Advisory panel: Immunology
Date received: 2021-11-03
Decision date: 2023-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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