ARCHITECT FREE PSA
FDA premarket approval P980007/S024 · decided 2011-12-21
Approval details
- PMA number
- P980007
- Supplement
- S024
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARCHITECT FREE PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2011-11-23
- Decision date
- 2011-12-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING OF AN INCOMING RAW MATERIAL USED FOR MANUFACTURING THE DEVICE AND IT¿S FINISHED ACCESSORY.
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