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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
Recalls CDRH Recalls
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