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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 K023597
Device Name ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
Applicant
BECKMAN COULTER, INC.
7330 CARROLL RD.
SAN DIEGO,  CA  92121
Applicant Contact MARA CALER
Correspondent
BECKMAN COULTER, INC.
7330 CARROLL RD.
SAN DIEGO,  CA  92121
Correspondent Contact MARA CALER
Regulation Number866.6010
Classification Product Code
LTK  
Date Received10/28/2002
Decision Date 12/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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