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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametandem free psa assays
ApplicantBECKMAN COULTER, INC.
PMA NumberP970038
Supplement NumberS002
Date Received04/27/1999
Decision Date06/16/1999
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site located at beckman coulter, inc. , 1000 lake hazeltine drive, chaska, mn 55318.
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