ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P980041/S007 · decided 2006-01-30
Approval details
- PMA number
- P980041
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2006-01-18
- Decision date
- 2006-01-30
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- CHANGES TO THE ACCESS, ACCESS 2 AND SYNCHRON LXI 725 ANALYZER OPERATING SOFTWARE TO REMOVE THE DIL-AFP ASSAY PROTOCOL AND RESTORE THE SYSTEMS TO THEIR ORIGINAL FUNCTIONALITY.
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510(k) clearances by this applicant
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|---|---|---|
| Access BNP II (K252169) | Beckman Coulter, Inc. | 2026-03-24 |
| Access anti-HBc IgM (K254059) | Beckman Coulter, Inc. | 2026-03-13 |
| Access anti-HBc Total (K253687) | Beckman Coulter, Inc. | 2026-02-19 |
| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
| Access Rubella IgG (K250588) | Beckman Coulter, Inc. | 2025-11-17 |
| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804) | Beckman Coulter, Inc. | 2025-08-20 |