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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 FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantBeckman Coulter, Inc.
250 S. Kraemer Blvd. M/S
W-110
Brea, CA 92822
PMA NumberP970038
Supplement NumberS026
Date Received12/17/2013
Decision Date05/01/2014
Product Code MTG 
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 SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1.
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