ClearanceBrief
Company ยท US

Abbott Point Of Care Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.

22510(k) clearances (2 in 12 months)
77recalls (3 in 12 months)
69recalls that name a 510(k)

Product codes

CodeDeviceRecords
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph35
CGAGlucose Oxidase, Glucose12
JGSElectrode, Ion Specific, Sodium11
JPIDevice, Hematocrit Measuring9
MMIImmunoassay Method, Troponin Subunit6
GJSTest, Time, Prothrombin5
JBPActivated Whole Blood Clotting Time5
CGLElectrode, Ion Based, Enzymatic, Creatinine2
JFPElectrode, Ion Specific, Calcium2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)2
JQPCalculator/Data Processing Module, For Clinical Use2
DHASystem, Test, Human Chorionic Gonadotropin1
JFLPh Rate Measurement, Carbon-Dioxide1
JJTEnzyme Controls (Assayed And Unassayed)1
JJYMulti-Analyte Controls, All Kinds (Assayed)1
KHPAcid, Lactic, Enzymatic Method1
MYTBiosensor, Immunoassay, Cpk Or Isoenzymes1
NBCTest, Natriuretic Peptide1
QATBrain Trauma Assessment Test1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 26, 2026K261039i-STAT Crea cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGL
Jun 11, 2026K253051i-STAT hs-TnI cartridge with the i-STAT Alinity System
Abbott Point of Care, Inc.
MMI
May 2, 2025K244014i-STAT CG4+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CHL
Jan 3, 2025K240984i-STAT hs-TnI cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
MMI
Mar 27, 2024K234143i-STAT TBI Cartridge with the i-STAT Alinity System
Abbott Point of Care
QAT
Oct 27, 2023K230300i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
JFP
Oct 27, 2023K230285i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CHL
Oct 27, 2023K230275i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
JGS
Sep 15, 2023K223857i-STAT G3+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CHL
Sep 11, 2023K223755i-STAT G cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGA
Jul 28, 2023K223710i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGA
Aug 13, 2021K210958i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGA
Apr 9, 2020K200492i-STAT CG4+ Cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CHL
Feb 28, 2020K183680i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
JPI
Feb 14, 2020K191360i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
JFP
Feb 7, 2020K191298i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
JFL
Feb 7, 2020K183688i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
JGS
Feb 7, 2020K183678i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
CGA
Apr 10, 2017K163271i-Stat Alinity System with i-Stat Glucose test
Abbott Point of Care, Inc.
CGA
Jul 8, 2016K153357i-STAT Alinity System with i-STAT Sodium test
Abbott Point of Care, Inc.
JGS
Apr 16, 2015K133002i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
Abbott Point of Care, Inc.
DHA
Feb 8, 2011K103195I-STAT 1 WIRELESS ANALYZER
Abbott Point of Care, Inc.
CGA

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 29, 2026Abbott Point Of Care Inc.
i-STAT G3+ cartridge; List Number: 03P78-26;
Open, Classified
CHLK223857
Apr 29, 2026Abbott Point Of Care Inc.
i-STAT EG6+ cartridge; List Number: 03P77-25;
Open, Classified
CHLK940918
Apr 29, 2026Abbott Point Of Care Inc.
i-STAT EG7+ cartridge; List Number: 03P76-25;
Open, Classified
CHLK940918
Sep 17, 2025Abbott Point Of Care Inc.
i-STAT EG6+ cartridge. List Number: 03P77-25.
Open, Classified
CHLNone listed
Sep 17, 2025Abbott Point Of Care Inc.
i-STAT EG7+ cartridge. List Number: 03P76-25.
Open, Classified
CHLNone listed
Sep 17, 2025Abbott Point Of Care Inc.
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Open, Classified
CHLNone listed
Sep 17, 2025Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Open, Classified
CHLK244014
K940918 +1
Dec 22, 2020Abbott Point Of Care Inc.
Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Numb
Terminated
CHLK940918
Dec 22, 2020Abbott Point Of Care Inc.
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood Lis
Terminated
CHLK940918
Feb 18, 2020Abbott Point Of Care Inc.
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial
Terminated
CHLNone listed
Feb 18, 2020Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous
Terminated
KHPNone listed
Feb 18, 2020Abbott Point Of Care Inc.
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, bl
Terminated
JGSNone listed
Oct 16, 2019Abbott Point Of Care Inc.
i-STAT cTnI cartridge
Terminated
MMIK031739
K051433
Sep 13, 2018Abbott Point Of Care Inc.
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)
Terminated
CHLK940918
Sep 12, 2017Abbott Point Of Care Inc.
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Terminated
JQPNone listed
Aug 10, 2015Abbott Point Of Care Inc.
i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring pati
Terminated
GJSK020355
Mar 27, 2014Abbott Point Of Care Inc.
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Terminated
CHLK940918
Dec 4, 2013Abbott Point Of Care Inc.
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as C
Terminated
GJSK020355
Nov 2, 2012Abbott Point Of Care Inc.
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number
Terminated
JJTK030768
Aug 22, 2012Abbott Point Of Care Inc.
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac
Terminated
MMIK031739
Aug 9, 2012Abbott Point Of Care Inc.
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. C
Terminated
MYTK051433
Aug 9, 2012Abbott Point Of Care Inc.
i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma sampl
Terminated
NBCK053597
Aug 9, 2012Abbott Point Of Care Inc.
i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma sampl
Terminated
MMIK031739
Aug 8, 2012Abbott Point Of Care Inc.
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Terminated
GJSK020355
Aug 2, 2012Abbott Point Of Care Inc.
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, parti
Terminated
CHLK940918
Jul 9, 2012Abbott Point Of Care Inc.
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 2
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as por
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analy
Terminated
CHLK001387
Jul 9, 2012Abbott Point Of Care Inc.
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the
Terminated
CHLK001387
Nov 10, 2011Abbott Point Of Care Inc.
i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.
Terminated
MMIK031739
Apr 18, 2011Abbott Point Of Care Inc.
i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyt
Terminated
JGSK053110
Apr 1, 2011Abbott Point Of Care Inc.
Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test.
Terminated
JJXK031873
Apr 1, 2011Abbott Point Of Care Inc.
Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02. Used to ver
Terminated
JJXK031873
Mar 10, 2011Abbott Point Of Care Inc.
i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pres
Terminated
CHLK940918
Feb 16, 2011Abbott Point Of Care Inc.
Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients und
Terminated
JBPK992571
Feb 2, 2011Abbott Point of Care Inc.
i-STAT Level 2 Control Value Assignment Sheets Human Consumption
Terminated
JJYNone listed
Jan 20, 2011Abbott Point of Care Inc.
i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in ar
Terminated
CHLK940918
Jan 20, 2011Abbott Point of Care Inc.
i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide
Terminated
CHLK940918
Dec 10, 2010Abbott Point Of Care Inc.
Military Kit Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the
Terminated
CGAK001387
Dec 10, 2010Abbott Point Of Care Inc.
i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat
Terminated
CGAK001387
Dec 10, 2010Abbott Point Of Care Inc.
Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable ana
Terminated
CHLK940918
Dec 10, 2010Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable
Terminated
CHLK940918
Dec 10, 2010Abbott Point Of Care Inc.
FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analy
Terminated
CHLK940918
Dec 10, 2010Abbott Point Of Care Inc.
i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer
Terminated
CHLK940918
Nov 24, 2010Abbott Point of Care Inc.
i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
Terminated
CGLK973292
Nov 17, 2010Abbott Point Of Care Inc.
i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
Terminated
JBPK023582
Nov 17, 2010Abbott Point Of Care Inc.
i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
Terminated
JBPK992571
Nov 3, 2010Abbott Point Of Care Inc.
i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540
Terminated
CHLK053597

Newest 50 of 77.

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