FDA 510(k) Applications Submitted by Abbott Point of Care, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K163271 11/21/2016 i-Stat Alinity System with i-Stat Glucose test Abbott Point of Care, Inc.
K200492 02/28/2020 i-STAT CG4+ Cartridge with the i-STAT 1 System Abbott point of Care, Inc.
K191360 05/21/2019 i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc.
K183678 12/28/2018 i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott point of Care, Inc.
K183688 12/28/2018 i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc.


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