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510(k) K213517

Access Thyroglobulin Antibody II by Beckman Coulter, Inc. — Product Code JZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2023
Date Received
November 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroid Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

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