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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 PSA Reagents on the Access Immunoassay Systems
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantBeckman Coulter, Inc.
250 S. Kraemer Blvd. M/S
W-110
Brea, CA 92822
PMA NumberP850048
Supplement NumberS052
Date Received05/13/2019
Decision Date08/09/2019
Product Code MTF 
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 piston rod design in the vacuum pump of the UniCel DxI 600 and 800 instruments, integrating the washer and piston rod into a single unit.
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