ABBOTT AXSYM AFP
FDA premarket approval P820060/S022 · decided 2008-03-26
Approval details
- PMA number
- P820060
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT AXSYM AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2007-08-21
- Decision date
- 2008-03-26
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR RE-STANDARDIZATION OF THE MANUFACTURING PROCESS FOR AXSYM AFP CALIBRATORS AND CONTROLS AGAINST THE WORLD HEALTH ORGANIZATION (WHO) FIRST INTERNATIONAL STANDARD 72/225 OR ALPHA-FETOPROTEIN (AFP).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |