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510(k) K221225

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer by Beckman Coulter, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2022
Date Received
April 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

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