ARCHITECT TOTAL PSA ASSAY
FDA premarket approval P910007/S017 · decided 2009-05-29
Approval details
- PMA number
- P910007
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARCHITECT TOTAL PSA ASSAY
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2008-05-21
- Decision date
- 2009-05-29
- Days to decision
- 373 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR MIGRATION OF THE ARCHITECT TOTAL PSA ASSAY TO A NEWARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR.
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