PMA P910065S008
- Device
- IMMUNOASAY, PSA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S008
- Product code
- MTF
- Decision date
- 2012-02-13
- 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 THE ADDITION OF ONE FDA-CLEARED TOSOH AUTOMATED IMMUNOASSAY ANALYZER, THE AIA-900, FOR USE WITH THE ST AIA-PACK PA ASSAY.
Current openFDA PMA Record#
- Device
- IMMUNOASAY, PSA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S008
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2012-02-13
- Decision code
- APPR
- Date received
- 2011-03-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF ONE FDA-CLEARED TOSOH AUTOMATED IMMUNOASSAY ANALYZER, THE AIA-900, FOR USE WITH THE ST AIA-PACK PA ASSAY.