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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.
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameimmunoassay, psa
PMA NumberP910065
Supplement NumberS007
Date Received04/24/2009
Decision Date11/30/2009
Product Code
MTF[ Registered Establishments with MTF ]
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 adding the assay of tosoh st aia-pack. Psa (prostate specific antigen) to the tosoh a1a-2000 st/la instrument, and extension of the calibration curve stability for the st aia-pack pa psa assay from 60 days to 90 days for aia nex. Ia, aia- 600 ii, aia-360, aia-1800, and aia-2000.