Abbott Point of Care, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Abbott Point of Care, Inc. has 21 FDA 510(k) cleared chemistry devices. Based in Princton, US.
Latest FDA clearance: Jun 2026. Active since 2011.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Abbott Point of Care, Inc.
21 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