Abbott Point of Care, Inc. - FDA 510(k) Cleared Devices
19
Total
19
Cleared
0
Denied
FDA 510(k) cleared devices by Abbott Point of Care, Inc. Chemistry ✕
18 devices
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
Cleared
Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Chemistry
269d
Cleared
Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Chemistry
406d
Cleared
Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Chemistry
406d
Cleared
Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Chemistry
269d
Cleared
Apr 10, 2017
i-Stat Alinity System with i-Stat Glucose test
Chemistry
140d
Cleared
Jul 08, 2016
i-STAT Alinity System with i-STAT Sodium test
Chemistry
231d
Cleared
Apr 16, 2015
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total...
Chemistry
569d
Cleared
Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
Chemistry
102d