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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCA 125 ANTIBODY RIA
Generic NameTEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
Regulation Number866.6010
ApplicantCentocor, Inc.
200 Great Valley Pkwy.
Malvern, PA 19355
PMA NumberP850009
Supplement NumberS007
Date Received12/08/1993
Decision Date12/21/1994
Product Code LTK 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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