PMA P980007S045
- Device
- ARCHITECT Free PSA (LN 6C07)
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S045
- Product code
- MTG
- Decision date
- 2021-12-06
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- Replace a sterile with a non-sterile bulk container for a kit component.
Current openFDA PMA Record#
- Device
- ARCHITECT Free PSA (LN 6C07)
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S045
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2021-12-06
- Decision code
- OK30
- Date received
- 2021-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace a sterile with a non-sterile bulk container for a kit component.