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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 reagent pack
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 NumberS059
Date Received04/25/2023
Decision Date05/25/2023
Product Code MTF 
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  
Revision of conjugate pooling and prefill/postfill testing specifications utilized in the Access Hybritech PSA Assay
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