Abbott Point of Care, Inc.
Dispositifs autorisés FDA 510(k) et PMA — 19 produits
Publicité
Nombre total de dispositifs19
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261039 | i-STAT Crea cartridge with the i-STAT 1 System | CGL | 2026-06-26 | Voir |
| 510(k) | K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | MMI | 2026-06-11 | Voir |
| 510(k) | K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | CHL | 2025-05-02 | Voir |
| 510(k) | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | MMI | 2025-01-03 | Voir |
| 510(k) | K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | CHL | 2023-10-27 | Voir |
| 510(k) | K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System | JGS | 2023-10-27 | Voir |
| 510(k) | K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | JFP | 2023-10-27 | Voir |
| 510(k) | K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | CHL | 2023-09-15 | Voir |
| 510(k) | K223755 | i-STAT G cartridge with the i-STAT 1 System | CGA | 2023-09-11 | Voir |
| 510(k) | K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | CGA | 2023-07-28 | Voir |
| 510(k) | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | CGA | 2021-08-13 | Voir |
| 510(k) | K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | CHL | 2020-04-09 | Voir |
| 510(k) | K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JPI | 2020-02-28 | Voir |
| 510(k) | K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JFP | 2020-02-14 | Voir |
| 510(k) | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JFL | 2020-02-07 | Voir |
| 510(k) | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | CGA | 2020-02-07 | Voir |
| 510(k) | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JGS | 2020-02-07 | Voir |
| 510(k) | K163271 | i-Stat Alinity System with i-Stat Glucose test | CGA | 2017-04-10 | Voir |
| 510(k) | K153357 | i-STAT Alinity System with i-STAT Sodium test | JGS | 2016-07-08 | Voir |
Aucun dispositif correspondant.