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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 K962559
Device Name ACS CORTISOL IMMUNOASSAY
Applicant
CIBA CORNING DIAGNOSTICS CORP.
17392 DAIMLER ST.
IRVINE,  CA  92714
Applicant Contact THOMAS F FLYN
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
17392 DAIMLER ST.
IRVINE,  CA  92714
Correspondent Contact THOMAS F FLYN
Regulation Number862.1205
Classification Product Code
JFT  
Date Received07/01/1996
Decision Date 11/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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