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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 K842455
Device Name AMER. BIO-SCIENCE LAB CORTISOL REAGENT
Applicant
American Bio-Science Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Bio-Science Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1205
Classification Product Code
CGR  
Date Received06/22/1984
Decision Date 08/16/1984
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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