- Device
- ARCHITECT FREE PSA AND AXSYM FREE PSA
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S027
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2012-12-11
- Decision code
- OK30
- Date received
- 2012-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED BRIJ L23 SOLUTION.