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510(k) K190773

Elecsys TSH by Roche Diagnostics — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2019
Date Received
March 26, 2019
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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