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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 K021218
Device Name ELECSYS CORTISOL TEST SYSTEM
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Applicant Contact SHERRI L COENEN
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Correspondent Contact SHERRI L COENEN
Regulation Number862.1205
Classification Product Code
JFT  
Date Received04/17/2002
Decision Date 09/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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