FDA 510(k) Applications Submitted by ABBOTT POINT OF CARE INC.

FDA 510(k) Number Submission Date Device Name Applicant
K230275 02/01/2023 i-STAT CG8+ cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K230300 02/03/2023 i-STAT CG8+ cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K244014 12/26/2024 i-STAT CG4+ cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K240984 04/10/2024 i-STAT hs-TnI cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K223710 12/12/2022 i-STAT CG8+ cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K103195 10/29/2010 I-STAT 1 WIRELESS ANALYZER ABBOTT POINT OF CARE INC.
K210958 03/31/2021 i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K133002 09/24/2013 i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials ABBOTT POINT OF CARE INC.
K153357 11/20/2015 i-STAT Alinity System with i-STAT Sodium test ABBOTT POINT OF CARE INC.
K223755 12/15/2022 i-STAT G cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K191298 05/14/2019 i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K183680 12/28/2018 i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care Inc.


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