ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P980041/S022 · decided 2013-03-25
Approval details
- PMA number
- P980041
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2013-01-23
- Decision date
- 2013-03-25
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE D
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 |
|---|---|---|
| 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 |