| Z-2583-2025 | Class II | i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K23027 | August 21, 2025 |
| Z-2584-2025 | Class II | i-STAT EG7+ cartridge. List Number: 03P76-25. | August 21, 2025 |
| Z-2585-2025 | Class II | i-STAT EG6+ cartridge. List Number: 03P77-25. | August 21, 2025 |
| Z-2582-2025 | Class II | i-STAT CG4+ cartridge (white). List Number: 03P85-25. | August 21, 2025 |
| Z-0880-2021 | Class II | Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ioni | December 22, 2020 |
| Z-0881-2021 | Class II | Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, i | December 22, 2020 |
| Z-1262-2020 | Class II | i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-S | January 15, 2020 |
| Z-1263-2020 | Class II | i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT | January 15, 2020 |
| Z-1265-2020 | Class II | i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT | January 14, 2020 |
| Z-0761-2020 | Class II | i-STAT cTnI cartridge | October 16, 2019 |
| Z-0615-2019 | Class II | Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arteri | September 13, 2018 |
| Z-0926-2018 | Class II | i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46- | September 12, 2017 |
| Z-2361-2015 | Class II | i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one | June 15, 2015 |
| Z-1306-2014 | Class II | i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and trea | January 1, 2014 |
| Z-0451-2014 | Class II | Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a pr | October 28, 2013 |
| Z-0192-2013 | Class III | Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 0710 | July 19, 2012 |
| Z-2237-2012 | Class II | i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for | March 7, 2012 |
| Z-2157-2012 | Class II | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is u | March 1, 2012 |
| Z-2171-2012 | Class II | i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic | February 1, 2012 |
| Z-2170-2012 | Class II | i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic t | February 1, 2012 |