- Device
- ARCHITECT FREE PSA (LN 6C07)
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S040
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2015-08-13
- Decision code
- OK30
- Date received
- 2015-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.