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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 K862871
Device Name RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
Applicant
Cambridge Medical Technology
575 Middlesex Tpke.
Billerica,  MA  01865
Applicant Contact ANNE M KULIS
Correspondent
Cambridge Medical Technology
575 Middlesex Tpke.
Billerica,  MA  01865
Correspondent Contact ANNE M KULIS
Regulation Number862.1205
Classification Product Code
CGR  
Date Received07/29/1986
Decision Date 08/19/1986
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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