ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS
FDA premarket approval P970038/S008 · decided 2006-05-18
Approval details
- PMA number
- P970038
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2006-04-10
- Decision date
- 2006-05-18
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE ACCESS PSA REAGENTS FOR USE ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCESS FREE PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM.
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