Abbott Laboratories
FDA 510(k) & PMA Approved Dispositivos — 28 products
Publicidade
Total de dispositivos28
Categorias0
Última decisão da FDA
| Tipo | Número | Nome do dispositivo | Código | Data | Ações |
|---|---|---|---|---|---|
| 510(k) | K262156 | Anti-HCV Next | MZO | 2026-09-23 | Ver |
| 510(k) | K252424 | Anti-HCV Next | MZO | 2026-04-28 | Ver |
| 510(k) | K243500 | ARCHITECT iGentamicina | LCD | 2025-07-09 | Ver |
| 510(k) | K243168 | Alinity i Rubella IgG | LFX | 2025-06-20 | Ver |
| 510(k) | K243283 | Sistema h-series Alinity | GKZ | 2025-02-20 | Ver |
| 510(k) | K233932 | Alinity i Toxo IgM | LGD | 2024-08-30 | Ver |
| 510(k) | K232669 | TBI | QAT | 2023-09-29 | Ver |
| 510(k) | K222850 | HAVAb IgG II | LOL | 2023-08-10 | Ver |
| 510(k) | K220031 | Sistema h-series Alinity | GKZ | 2023-08-04 | Ver |
| 510(k) | K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | GJS | 2023-07-14 | Ver |
| 510(k) | K230937 | Kit de Reagente Total ß-hCG Alinity i, Sistemas GLP Track | DHA | 2023-06-05 | Ver |
| 510(k) | K230790 | Kit de Reagente Total B-hCG Alinity i, Kit de Reagente de Glicose Alinity c, Disolvente de Amostra ICT Alinity c, Série Alinity ci | DHA | 2023-05-19 | Ver |
| 510(k) | K223602 | Traumatic brain injury (TBI) test | QAT | 2023-03-02 | Ver |
| 510(k) | K220949 | Arquiteto CMV IgG | LFZ | 2022-10-27 | Ver |
| 510(k) | K210596 | ARCHITECT Toxo IgG | LGD | 2022-05-19 | Ver |
| 510(k) | K213486 | GLP systems Track | JGS | 2022-03-10 | Ver |
| 510(k) | K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | QAT | 2021-01-08 | Ver |
| 510(k) | K190294 | CELL-DYN Emerald 22 AL System | GKZ | 2019-03-15 | Ver |
| 510(k) | K181748 | Magnesium | JGJ | 2018-09-12 | Ver |
| 510(k) | K173294 | Magnesium | JGJ | 2018-05-18 | Ver |
Nenhum dispositivo correspondente.