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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAIA PACK PA
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantTOSOH BIOSCIENCE, INC.
6000 SHORELINE COURT
SUITE 101
SOUTH SAN FRANCISCO, CA 94080
PMA NumberP910065
Supplement NumberS002
Date Received12/16/1999
Decision Date03/03/2000
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of the AIA 600 II analyzer instrument to the list of approved analyzers using the AIA-Pack PA assay.
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