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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.
 
DeviceIMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
GLYN RHONWY, LLANBERIS
GWYNEDD LL55 4EL LL554
PMA NumberP930027
Date Received08/10/1993
Decision Date09/15/1995
Product Code MTF 
Docket Number 96M-0217
Notice Date 09/12/1996
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE COAT-A-COUNT PSA IRMA
Approval OrderApproval Order
Supplements: S012 S013  S001 S004 S015 S014 S008 S003 S006 S011 S016 
S005 S007 S010 S017 S018 S021 S023 S024 S019 S020 S022 S028 
S026 S027 S025 
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