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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.
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate specific antigen assay (psa)
Regulation Number866.6010
ApplicantBAYER CORP.
PMA NumberP950021
Supplement NumberS003
Date Received09/28/2000
Decision Date08/06/2001
Product Code
LTJ[ Registered Establishments with LTJ ]
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 processing and final packaging at bayer diagnostics, walpole, massachusetts.