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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 NameIMMULITE PSA CATALOG # LKPS1,5)
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Namepsa test kit
Regulation Number866.6010
ApplicantDIAGNOSTIC PRODUCTS CORP.
PMA NumberP930027
Supplement NumberS003
Date Received02/20/1998
Decision Date05/08/1998
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding information on the percentage for each psa range for healthy male subjects as one group in the expected value section.
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