PMA P910065S007
- Device
- ST AIA-PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S007
- Product code
- MTF
- Decision date
- 2009-11-30
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- 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.
Current openFDA PMA Record#
- Device
- ST AIA-PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S007
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2009-11-30
- Decision code
- APPR
- Date received
- 2009-04-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.