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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 NumberS002
Date Received12/16/1999
Decision Date03/03/2000
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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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