ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 SYSTEM
FDA premarket approval P970038/S006 · decided 2003-01-09
Approval details
- PMA number
- P970038
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 SYSTEM
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2002-10-07
- Decision date
- 2003-01-09
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL TO ADD THE ACCESS HYBRITECH FREE PSA ASSAY TO THE SYNCHRON LXI 725 SYSTEM.
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