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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
PMA NumberP910065
Date Received11/13/1991
Decision Date07/07/1993
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 93M-0251
Notice Date 08/10/1993
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008