ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P850048/S022 · decided 2007-09-18
Approval details
- PMA number
- P850048
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2007-05-16
- Decision date
- 2007-09-18
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE USE OF THE ACCESS (HYBRITECH) PSA REAGENTS ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM.
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