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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 REAGENT/CALIBRATOR KIT
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantBECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD M/S
W-110
BREA, CA 92822
PMA NumberP970038
Supplement NumberS029
Date Received11/04/2014
Decision Date03/20/2015
Product Code MTG 
Advisory Committee Immunology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.
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