- Device
- ARCHITECT TOTAL PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S021
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2011-07-26
- Decision code
- APPR
- Date received
- 2010-11-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD IN SINGAPORE.