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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 IMMUNOASSAY
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 NumberS004
Date Received10/06/2006
Decision Date10/13/2006
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the package insert which includes modification of the equimolarity statement found in the summary section, addition of lob/lod information and minor editorial revisions.
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