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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.
 
DeviceAccess AFP Reagents on the Access Immunoassay Systems
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantBeckman Coulter, Inc.
250 S. Kraemer Blvd. M/S
W-110
Brea, CA 92822
PMA NumberP980041
Supplement NumberS036
Date Received03/22/2017
Decision Date06/16/2017
Product Code LOK 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modification to the UniCel Dxl Clinical System's sample probe to improve the manufacturability of the component.
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