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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 TOTAL PSA CALSET
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameelectrochemiluminescence assay for the determination of prostate specific antigen;psa calibrator
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP990056
Supplement NumberS006
Date Received12/28/2006
Decision Date01/19/2007
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the labeling in the precautions and warnings section, concerning the testing of potentially infectious human-derived material used in the assay.
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