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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 Fetoprotien (AFP) Assay
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSiemens Healthcare Diagnostics, Inc.
333 Coney St.
East Walpole, MA 02032
PMA NumberP930036
Supplement NumberS014
Date Received03/09/2020
Decision Date04/03/2020
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).
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