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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-MP PSA IMMUNOENZYMETRIC ASSAY
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate_specific antigen (psa) for management of prostate cancer
Regulation Number866.6010
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Supplement NumberS014
Date Received05/19/1999
Decision Date06/16/1999
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site located at beckman coulter, inc. , 1000 lake hazeltine dr. , chaska, mn 55318.
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