510(k) K973292 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
I-STAT SYSTEM
| Applicant | I-Stat Corp., Princeton NJ, US |
| Decision | Substantially Equivalent, Oct 20, 1997 |
| Received | Sep 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2010 | Abbott 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 |
CGL | None listed |
| Dec 11, 2007 | Abbott Point of Care Inc. Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 320100; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada. Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.