PMA P910065S009
- Device
- AIA-PACK PSA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S009
- Product code
- MTF
- Decision date
- 2019-06-18
- 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 labeling changes to the Tosoh AIA-PACK PSA Test to reflect newly acquired information that enhances the safety of the device as allowed by 21 CFR 814.39(d).
Current openFDA PMA Record#
- Device
- AIA-PACK PSA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S009
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2019-06-18
- Decision code
- APPR
- Date received
- 2019-05-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes to the Tosoh AIA-PACK PSA Test to reflect newly acquired information that enhances the safety of the device as allowed by 21 CFR 814.39(d).