AMERSHAM AFP
FDA premarket approval P780006 · decided 1984-06-07
Approval details
- PMA number
- P780006
- Trade name
- AMERSHAM AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Ortho Clinical Diagnostics
- Date received
- 1978-10-12
- Decision date
- 1984-06-07
- Days to decision
- 2065 days
- Decision code
- APWD
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Rochester, NY
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 |
|---|---|---|
| VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534) | Ortho Clinical Diagnostics | 2024-08-28 |
| VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581) | Ortho Clinical Diagnostics | 2024-05-08 |
| VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (K221197) | Ortho Clinical Diagnostics | 2023-09-05 |
| VITROS Immunodiagnostic Products CEA Reagent Pack (K231517) | Ortho Clinical Diagnostics | 2023-08-23 |
| VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) | Ortho Clinical Diagnostics | 2023-08-09 |
| VITROS Immuodiagnostic Products CA 125 II Reagent Pack (K221355) | Ortho Clinical Diagnostics | 2022-12-12 |
| VITROS AFP (K213626) | Ortho Clinical Diagnostics | 2022-06-15 |
| VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648) | Ortho Clinical Diagnostics | 2022-01-28 |