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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.
 
DeviceELECSYS FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, IN 46250
PMA NumberP000027
Supplement NumberS015
Date Received02/29/2012
Decision Date03/28/2012
Product Code
MTG
Advisory Committee Immunology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer the rework location from building r to a connected building w2 on the indianapolis campus for the device.
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