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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 NameAIA-PACK PA
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameimmunoassay, psa
Regulation Number866.6010
ApplicantTOSOH BIOSCIENCE, INC.
PMA NumberP910065
Supplement NumberS003
Date Received01/09/2002
Decision Date09/09/2002
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the location of the manufacturing facility of the ascites fluid used in the preparation of the monoclonal antibodies from the tosoh tokyo research center in ayase, japan to nisseiken, co. Ltd. In tokyo, japan.
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