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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 IMMUNOASSAY
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 NumberS023
Date Received12/19/2007
Decision Date02/26/2008
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 REFORMULATED WASH BUFFER, WASH BUFFER II, ON THE ACCESS IMMUNOASSAY SYSTEMS.
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