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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fluorometric, cortisol
510(k) Number K152227
Device Name Elecsys Cortisol II, Cortisol II CalSet
Applicant
ROCHE DIAGNOSTICS
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250
Applicant Contact KELLI TURNER
Correspondent
ROCHE DIAGNOSTICS
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250
Correspondent Contact KELLI TURNER
Regulation Number862.1205
Classification Product Code
JFT  
Subsequent Product Code
JIT  
Date Received08/07/2015
Decision Date 04/27/2016
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
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