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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, epithelial ovarian tumor-associated antigen (ca125)
510(k) Number K983875
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact ANNE ZAVERTNIK
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact ANNE ZAVERTNIK
Regulation Number866.6010
Classification Product Code
LTK  
Date Received11/02/1998
Decision Date 05/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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