Abbott Point of Care, Inc. - FDA 510(k) Cleared Devices
Recent clearances: i-STAT CG4+ cartridge with the i-STAT 1 System, i-STAT hs-TnI cartridge with the i-STAT 1 System, i-STAT CG8+ cartridge with the i-STAT 1 System
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Point of Care, Inc. Chemistry ✕
20 devices
Cleared
Jun 26, 2026
i-STAT Crea cartridge with the i-STAT 1 System
Chemistry
88d
Cleared
Jun 11, 2026
i-STAT hs-TnI cartridge with the i-STAT Alinity System
Chemistry
262d
Cleared
May 02, 2025
i-STAT CG4+ cartridge with the i-STAT 1 System
Chemistry
127d
Cleared
Jan 03, 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
Chemistry
268d
Cleared
Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
Chemistry
268d
Cleared
Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
Chemistry
267d
Cleared
Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
Chemistry
266d
Cleared
Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
Chemistry
266d
Cleared
Sep 11, 2023
i-STAT G cartridge with the i-STAT 1 System
Chemistry
270d
Cleared
Jul 28, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
Chemistry
228d
Cleared
Aug 13, 2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Chemistry
135d
Cleared
Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
Chemistry
41d