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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 NumberS015
Date Received07/12/1999
Decision Date08/03/1999
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change in a raw material from bovine serum to bovine serum albumin, which is used in the manufacture of a component in the tandem(r)-mp psa kit to improve the consistency between lots. In addition, a change in the microplate vendor to permit an additional source of microplates and to reduce manufacturing costs.
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