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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, thyroid-stimulating hormone
510(k) Number K162606
Device Name Elecsys TSH assay, cobas e 801 Immunoassay analyzer
Applicant
ROCHE DIAGNOSTICS
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250
Applicant Contact ANGELO PEREIRA
Correspondent
ROCHE DIAGNOSTICS
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250
Correspondent Contact ANGELO PEREIRA
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JJE  
Date Received09/19/2016
Decision Date 01/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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