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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, PSA CALSET & PSA CALCHECK
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 NumberS005
Date Received07/23/2007
Decision Date03/03/2009
Product Code MTG 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR EXTENSION OF THE ELECSYS TOTAL PSA SYSTEM ONTO AN UPDATED MODEL OF THE MODULAR ANALYTICS E170 ANALYZER, KNOWN AS THE COBAS E411 ANALYZER.
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