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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 TOTAL PSA IMMUNOASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, IN 46250
PMA NumberP990056
Supplement NumberS020
Date Received04/09/2013
Decision Date03/21/2014
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the software change from version 06-07 to 06-08 on theelecsys 2010 analyzer to correct the possibility of incorrect results after automatic dilution.
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