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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.
 
DeviceIMMULITE AFP ASSAY
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSiemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP010007
Supplement NumberS009
Date Received05/30/2012
Decision Date11/08/2012
Product Code LOK 
Advisory Committee Immunology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ELIMINATING THE TEST REDUNDANCY BY USING ONLY THE BIORADLYPHOCHECK IMMUNOASSAY PLUS CONTROLS IN IN-PROCESS COMPONENT TESTING, POST-FILL TESTING AND FINAL KIT COMBINATION TESTING FOR THE ASSESSMENT OF IMMULITE AFP, FREE PSA, AND PSA/3RD GENERATION PSA ASSAY PERFORMANCE.
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