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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.
 
Trade NameAXSYM TOTAL PSA & ARCHITECT TOTAL PSA
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameabbolabo
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Date Received03/01/1991
Decision Date09/25/1991
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 91M-0411
Notice Date 11/12/1991
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 
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