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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameELECSYS FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP000027
Supplement NumberS019
Date Received04/04/2014
Decision Date06/12/2014
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for release of cobas 8000 software version 04-01 and cobas 8000 data manager software version 1. 03.
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