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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 K042731
Device Name ARCHITECT CA 125 II ASSAY
Applicant
FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN,  PA  19355 -1307
Applicant Contact KIMBERLY PETERSON
Correspondent
FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN,  PA  19355 -1307
Correspondent Contact KIMBERLY PETERSON
Regulation Number866.6010
Classification Product Code
LTK  
Subsequent Product Codes
JIT   JJX  
Date Received10/01/2004
Decision Date 11/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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