510(k) K001154 ยท JGS Electrode, Ion Specific, Sodium
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
| Applicant | I-Stat Corp., East Windsor NJ, US |
| Decision | Substantially Equivalent, Apr 18, 2000 |
| Received | Apr 10, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001154
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2007 | Abbott Point of Care Inc. Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01; Part No: 121000; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada. Terminated |
JGS | None listed |
| Dec 11, 2007 | Abbott Point of Care Inc. Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No: 121500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada. Terminated |
JGS | None listed |
| Dec 11, 2007 | Abbott Point of Care Inc. Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada. Terminated |
JGS | None listed |
| Dec 11, 2007 | Abbott Point of Care Inc. Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; 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.