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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 Hybritech p2PSA Reagents on the Access Immunoassay Systems
Generic NameP2psa
ApplicantBECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318
PMA NumberP090026
Supplement NumberS022
Date Received09/25/2018
Decision Date12/21/2018
Product Code OYA 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a modification to the Unicel Dxl Clinical System's reagent pipettor gantry and to the reagent vessel carriage by changing the carriage motor and carriage rail suppliers to simplify the design resulting in improvements to manufacturability, service and assembly and cost reduction.
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