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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.
 
DeviceAtellica IM Alpha Fetoprotein (AFP) Assay
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
333 CONEY STREET
EAST WALPOLE, MA 02032
PMA NumberP930036
Supplement NumberS011
Date Received02/01/2019
Decision Date03/08/2019
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Adding an additional manufacturing site for the instrument module.
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