ARCHITECT TOTAL PSA (LN 6C06)
FDA premarket approval P910007/S023 · decided 2011-06-08
Approval details
- PMA number
- P910007
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT TOTAL PSA (LN 6C06)
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2010-11-22
- Decision date
- 2011-06-08
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTIC DIVISION IN SLIGO, IRELAND.
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