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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.
 
DeviceST AIA-PACK PA
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Applicant
TOSOH BIOSCIENCE, INC.
6000 shoreline court
suite 101
south san francisco, CA 94080
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/material
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 CURVESTABILITY 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.
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