ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P850048/S019 · decided 2003-03-03
Approval details
- PMA number
- P850048
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2002-12-20
- Decision date
- 2003-03-03
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL TO ADD THE ACCESS HYBRITECH PSA ASSAY TO THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM.
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510(k) clearances by this applicant
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|---|---|---|
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| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
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| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
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