PMA P980007S033
- Device
- ARCHITECT FREE PSA
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S033
- Product code
- MTG
- Decision date
- 2014-02-03
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- CHANGE TO THE QUALITY CONTROL TESTING USED ON IN-PROCESS MATERIALS.
Current openFDA PMA Record#
- Device
- ARCHITECT FREE PSA
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S033
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2014-02-03
- Decision code
- OK30
- Date received
- 2014-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE QUALITY CONTROL TESTING USED ON IN-PROCESS MATERIALS.