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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.
 
DeviceELECSYS FREE PSA IMMUNOASSAY
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP000027
Supplement NumberS021
Date Received10/07/2015
Decision Date11/24/2015
Product Code MTG 
Advisory Committee Immunology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE TESTING PROCEDURE FOR THE STREPTAVIDIN-COATED MICROPARTICLES COMPONENT USED AS THE SOLID PHASE IN ELECSYS IMMUNOASSAYS.
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