- Device
- ARCHITECT TOTAL PSA (LN 6C06)
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S023
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2011-06-08
- Decision code
- APPR
- Date received
- 2010-11-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTIC DIVISION IN SLIGO, IRELAND.