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. |
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Device | ST AIA-PACK PA |
Generic Name | Total, 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 Number | P910065 |
Supplement Number | S007 |
Date Received | 04/24/2009 |
Decision Date | 11/30/2009 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Normal 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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