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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 TOTAL PSA (TPSA) TEST SYSTEM
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 NumberS014
Date Received08/01/2011
Decision Date02/24/2012
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR EXTENSION OF THE ELECSYS TOTAL PSA (TPSA) TEST SYSTEM ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER.
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