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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
333 CONEY STREET
EAST WALPOLE, MA 02032
PMA NumberP930036
Date Received10/18/1993
Decision Date09/29/1995
Product Code LOK 
Docket Number 95M-0195
Notice Date 07/03/1996
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CIBA CORNING ACS AFP IMMUNOASSAY
Supplements:  S005 S004 S001 S002 S006 S003 S007 S013 S014 S018 S020 
S017 S016 S019 S008 S009 S010 S011 S012 S015 S021 S022 
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