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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 PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
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 NumberS042
Date Received07/28/2016
Decision Date08/26/2016
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  
Manufacturing process change to use PSA reference calibrators instead of commercial calibrators to establish a valid calibration curve during the in-process qualification of the coated PSA paramagnetic particles.
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