ABBOTT ARCHITECT FREE PSA
FDA premarket approval P980007/S002 · decided 2004-02-05
Approval details
- PMA number
- P980007
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT ARCHITECT FREE PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2002-02-01
- Decision date
- 2004-02-05
- Days to decision
- 734 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ARCHITECT FREE PSA ASSAY.
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