AXSYM FREE PSA & ARCHITECT FREE PSA
FDA premarket approval P980007/S022 · decided 2011-09-13
Approval details
- PMA number
- P980007
- Supplement
- S022
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AXSYM FREE PSA & ARCHITECT FREE PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2011-09-07
- Decision date
- 2011-09-13
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR ADDITION OF A BSA SCREENING TEST TO IDENTIFY PROTEASE CONTAMINATION IN VENDOR LOTS OF INCOMING BSA PRIOR TO PURCHASE.
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