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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cortisol
510(k) Number K852939
Device Name CORTISOL SYSTEM BY EIA
Applicant
American Bioclinical, Inc.
P.O. Box 12669
Portland,  OR  97212
Applicant Contact BILL LEDFORD
Correspondent
American Bioclinical, Inc.
P.O. Box 12669
Portland,  OR  97212
Correspondent Contact BILL LEDFORD
Regulation Number862.1205
Classification Product Code
CGR  
Date Received07/10/1985
Decision Date 08/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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