- Device
- ARCHITECT TOTAL PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S046
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2014-12-11
- Decision code
- OK30
- Date received
- 2014-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.