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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, free PSA CalSet, and free 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 NumberS027
Date Received08/28/2017
Decision Date07/27/2018
Product Code MTG 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the migration of Elecsys free PSA, free PSA CalSet and free PSA CalCheck on the cobas e 801 immunoassay analyzer
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