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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.
 
DeviceTANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
BECKMAN COULTER, INC.
250 south kraemer blvd m/s
w-110
brea, CA 92822
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/sterilizer/packager/supplier
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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