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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 NameTANDEM-R PSA IMMUNORADIOMETRIC ASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namepsa immunoradiometric assay
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Date Received07/09/1985
Decision Date02/25/1986
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 86M-0137
Notice Date 04/09/1986
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S011 S012 S013 
S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 
S026 S027 S028 S031 S032 
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