Medical Device Manufacturer · US , Princton , NJ

Abbott Point of Care, Inc.

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

Abbott Point of Care, Inc. — FDA 510(k) Submissions

Abbott Point of Care, Inc. has submitted 19 FDA 510(k) premarket notifications since 2011, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Glucose Oxidase, Glucose, Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, Electrode, Ion Specific, Sodium, Electrode, Ion Specific, Calcium, System, Test, Human Chorionic Gonadotropin . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · CHL Electrode Measurement,... · Chemistry
May 2025 127d
i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · MMI Immunoassay Method,... · Chemistry
Jan 2025 268d
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · JGS Electrode, Ion Specific,... · Chemistry
Oct 2023 268d
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · CHL Electrode Measurement,... · Chemistry
Oct 2023 267d
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300 · JFP Electrode, Ion Specific,... · Chemistry
Oct 2023 266d
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · CHL Electrode Measurement,... · Chemistry
Sep 2023 266d
i-STAT G cartridge with the i-STAT 1 System
K223755 · CGA Glucose Oxidase, Glucose · Chemistry
Sep 2023 270d
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · CGA Glucose Oxidase, Glucose · Chemistry
Jul 2023 228d
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958 · CGA Glucose Oxidase, Glucose · Chemistry
Aug 2021 135d
i-STAT CG4+ Cartridge with the i-STAT 1 System
K200492 · CHL Electrode Measurement,... · Chemistry
Apr 2020 41d
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183680 · JPI Device, Hematocrit Measuring · Hematology
Feb 2020 427d
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · JFP Electrode, Ion Specific,... · Chemistry
Feb 2020 269d
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · CGA Glucose Oxidase, Glucose · Chemistry
Feb 2020 406d
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · JGS Electrode, Ion Specific,... · Chemistry
Feb 2020 406d
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · JFL Ph Rate Measurement,... · Chemistry
Feb 2020 269d
i-Stat Alinity System with i-Stat Glucose test
K163271 · CGA Glucose Oxidase, Glucose · Chemistry
Apr 2017 140d
i-STAT Alinity System with i-STAT Sodium test
K153357 · JGS Electrode, Ion Specific,... · Chemistry
Jul 2016 231d
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
K133002 · DHA System, Test, Human... · Chemistry
Apr 2015 569d
I-STAT 1 WIRELESS ANALYZER
K103195 · CGA Glucose Oxidase, Glucose · Chemistry
Feb 2011 102d
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