510(k) K940918 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
I-STAT 200 PORTABLE CLINICAL ANALYZER
| Applicant | I-Stat Corp., Princeton NJ, US |
| Decision | Substantially Equivalent, May 10, 1994 |
| Received | Feb 25, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940918
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2026 | Abbott Point Of Care Inc. i-STAT EG7+ cartridge;
List Number: 03P76-25; Open, Classified |
CHL | None listed |
| Apr 29, 2026 | Abbott Point Of Care Inc. i-STAT EG6+ cartridge;
List Number: 03P77-25; Open, Classified |
CHL | None listed |
| Sep 17, 2025 | Abbott Point Of Care Inc. i-STAT CG4+ cartridge (white). List Number: 03P85-25. Open, Classified |
CHL | None listed |
| Dec 22, 2020 | Abbott 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 |
CHL | None listed |
| Dec 22, 2020 | Abbott 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 |
CHL | None listed |
| Sep 13, 2018 | Abbott 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 |
CHL | None listed |
| Mar 27, 2014 | Abbott 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 |
CHL | None listed |
| Aug 2, 2012 | Abbott 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 |
CHL | None listed |
| Mar 10, 2011 | Abbott 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 |
CHL | None listed |
| Jan 20, 2011 | Abbott 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 |
CHL | None listed |
| Jan 20, 2011 | Abbott 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 |
CHL | None listed |
| Dec 10, 2010 | Abbott 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 |
CHL | None listed |
| Dec 10, 2010 | Abbott 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 |
CHL | None listed |
| Dec 10, 2010 | Abbott 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 |
CHL | None listed |
| Dec 10, 2010 | Abbott 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 |
CHL | None listed |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT EG7+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a ke Terminated |
JPI | None listed |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT EG6+ cartridges
The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a ke Terminated |
JPI | None listed |
| Jun 18, 2009 | Abbott Point of Care Inc. i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct.
Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, E Terminated |
CHL | None listed |
| Jun 18, 2009 | Abbott Point of Care Inc. i-STAT G3+ Cartridge;
pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100.
Abbott Point of Care Inc.,
Abbott Pa Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.