MIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM
FDA premarket approval P980007/S009 · decided 2009-05-28
Approval details
- PMA number
- P980007
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2008-05-21
- Decision date
- 2009-05-28
- Days to decision
- 372 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR MIGRATION OF THE ARCHITECT FREE PSA ASSAY TO A NEWARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR.
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