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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 K062204
Device Name ARCHITECT CORTISOL ASSAY
Applicant
Seradyn, Inc.
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268
Applicant Contact EARL E KNIGHT
Correspondent
Seradyn, Inc.
7998 Georgetown Rd.
Suite 1000
Indianapolis,  IN  46268
Correspondent Contact EARL E KNIGHT
Regulation Number862.1205
Classification Product Code
JFT  
Subsequent Product Code
JIT  
Date Received08/01/2006
Decision Date 09/22/2006
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
Predetermined Change
Control Plan Authorized		 No
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