510(k) K053110 ยท JGS Electrode, Ion Specific, Sodium
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
| Applicant | I-Stat Corporation, East Windsor NJ, US |
| Decision | Substantially Equivalent, Jan 13, 2006 |
| Received | Nov 4, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053110
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. Open, Classified |
CGL | None listed |
| Apr 18, 2011 | Abbott 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 |
JGS | None listed |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT CHEM8+ 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 Terminated |
JPI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.