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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
Original Applicant
CIBA CORNING DIAGNOSTICS CORP.
63 north st.
medfield,  MA  02052 1688
Original Contact william j pignato
Regulation Number862.1205
Classification Product Code
JFT  
Date Received09/01/1993
Decision Date 05/13/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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