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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 K830148
Device Name CORTISOL KIT
Applicant
CAMBRIDGE MEDICAL TECHNOLOGY
MA 
Correspondent
CAMBRIDGE MEDICAL TECHNOLOGY
MA 
Regulation Number862.1205
Classification Product Code
CGR  
Date Received01/17/1983
Decision Date 02/09/1983
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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