Abbott Point of Care, Inc.
FDA 510(k) & PMA Approved Devices — 17 products
Total Devices17
Categories7
Latest Approval2025-05-02
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | CHL | 2025-05-02 | View |
| 510(k) | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | MMI | 2025-01-03 | View |
| 510(k) | K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | CHL | 2023-10-27 | View |
| 510(k) | K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System | JGS | 2023-10-27 | View |
| 510(k) | K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | JFP | 2023-10-27 | View |
| 510(k) | K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | CHL | 2023-09-15 | View |
| 510(k) | K223755 | i-STAT G cartridge with the i-STAT 1 System | CGA | 2023-09-11 | View |
| 510(k) | K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | CGA | 2023-07-28 | View |
| 510(k) | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | CGA | 2021-08-13 | View |
| 510(k) | K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | CHL | 2020-04-09 | View |
| 510(k) | K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JPI | 2020-02-28 | View |
| 510(k) | K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JFP | 2020-02-14 | View |
| 510(k) | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | CGA | 2020-02-07 | View |
| 510(k) | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JGS | 2020-02-07 | View |
| 510(k) | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JFL | 2020-02-07 | View |
| 510(k) | K163271 | i-Stat Alinity System with i-Stat Glucose test | CGA | 2017-04-10 | View |
| 510(k) | K153357 | i-STAT Alinity System with i-STAT Sodium test | JGS | 2016-07-08 | View |
No matching devices.