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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 NumberS010
Date Received10/16/2009
Decision Date12/03/2009
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of a larger test kit with 200 determinations instead of 100 determinations.
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