ACCESS HYBRITECH FREE PSA ASSAY
FDA premarket approval P970038/S012 · decided 2008-08-13
Approval details
- PMA number
- P970038
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH FREE PSA ASSAY
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2008-05-27
- Decision date
- 2008-08-13
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE ADDITION OF A CALIBRATION TRACEABLE TO THE WORLD HEALTH ORGANIZATION 1ST INTERNATIONAL REFERENCE PREPARATION 96/668 FOR THE ACCESS HYBRITECH FREE PSA ASSAY
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