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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 K934317
Device Name CIDBA CORNING ACS CORTISOL IMMUNOASSAY
Applicant
Ciba Corning Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Applicant Contact William J Pignato
Correspondent
Ciba Corning Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Correspondent Contact William J Pignato
Regulation Number862.1205
Classification Product Code
JFT  
Date Received09/01/1993
Decision Date 05/13/1994
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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