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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 NameCOMPLEXED PSA MICROTITER ELISA
Classification Nameantigen(complexed),prostate specific,(cpsa)
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP990055
Supplement NumberS003
Date Received09/20/2001
Decision Date03/13/2002
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing sites located at bayer diagnostics, elkhart, indiana and oncogene science, cambridge, massachusetts.
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