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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 Namekit, test, prostate specific antigen
Regulation Number866.6010
PMA NumberP850048
Supplement NumberS016
Date Received10/18/1999
Decision Date02/24/2000
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for addition of the access hybritech psa assay on the access immunoassay analyzer to other approved instrument platforms.