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510(k) K162606

Elecsys TSH assay, cobas e 801 Immunoassay analyzer by Roche Diagnostics — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2017
Date Received
September 19, 2016
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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