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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCA 125 ANTIBODY RIA
Classification Nametest, epithelial ovarian tumor-associated antigen (ca125)
Generic Nameepithelial ovarian tumor-associated antigen (ca1
Regulation Number866.6010
ApplicantCENTOCOR, INC.
PMA NumberP850009
Supplement NumberS006
Date Received09/15/1993
Decision Date03/23/1994
Product Code
LTK[ Registered Establishments with LTK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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