- Device
- ARCHITECT TOTAL PSA (LN 6C06)
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S045
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2014-06-18
- Decision code
- OK30
- Date received
- 2014-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE QUALITY CONTROL TESTING OF ARCHITECT FREE PSA PANELS G/I, ARCHITECT TOTAL PSA PANEL STOCK AND ARCHITECT TOTAL PSA PANELS K/Q.