ARCHITECT AFP and Alinity i AFP
FDA premarket approval P120008/S016 · decided 2020-11-05
Approval details
- PMA number
- P120008
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT AFP and Alinity i AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2020-10-16
- Decision date
- 2020-11-05
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Adding a process for overhead tank mixing of paramagnetic microparticles using the 650 L microparticle tank in order to improve the manufacturing flexibility of the assays.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
| ARCHITECT iGentamicin (K243500) | Abbott Laboratories | 2025-07-09 |
| Alinity i Rubella IgG (K243168) | Abbott Laboratories | 2025-06-20 |
| Alinity h-series System (K243283) | Abbott Laboratories | 2025-02-20 |
| Alinity i Toxo IgM (K233932) | Abbott Laboratories | 2024-08-30 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |