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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAIA-PACK PSA
Generic Nametotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Applicant
TOSOH BIOSCIENCE, INC.
6000 shoreline court
suite 101
south san francisco, CA 94080
PMA NumberP910065
Date Received11/13/1991
Decision Date07/07/1993
Product Code MTF 
Docket Number 93M-0251
Notice Date 08/10/1993
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 
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