Medical Device Manufacturer · US , Princton , NJ

Abbott Point of Care, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2011
19
Total
19
Cleared
0
Denied

Abbott Point of Care, Inc. has 19 FDA 510(k) cleared chemistry devices. Based in Princton, US.

Latest FDA clearance: May 2025. 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.
19 devices
1-19 of 19
Cleared May 02, 2025
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · CHL
Chemistry · 127d
Cleared Jan 03, 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · MMI
Chemistry · 268d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · JGS
Chemistry · 268d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · CHL
Chemistry · 267d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300 · JFP
Chemistry · 266d
Cleared Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · CHL
Chemistry · 266d
Cleared Sep 11, 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · CGA
Chemistry · 270d
Cleared Jul 28, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · CGA
Chemistry · 228d
Cleared Aug 13, 2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958 · CGA
Chemistry · 135d
Cleared Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
K200492 · CHL
Chemistry · 41d
Cleared Feb 28, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183680 · JPI
Hematology · 427d
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · JFP
Chemistry · 269d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · CGA
Chemistry · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · JGS
Chemistry · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · JFL
Chemistry · 269d
Cleared Apr 10, 2017
i-Stat Alinity System with i-Stat Glucose test
K163271 · CGA
Chemistry · 140d
Cleared Jul 08, 2016
i-STAT Alinity System with i-STAT Sodium test
K153357 · JGS
Chemistry · 231d
Cleared Apr 16, 2015
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total...
K133002 · DHA
Chemistry · 569d
Cleared Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
K103195 · CGA
Chemistry · 102d
Filters