510(k) K934642 ยท JFP Electrode, Ion Specific, Calcium
I-STAT IONIZED CALCIUM TEST
| Applicant | I-Stat Corp., Princeton NJ, US |
| Decision | Substantially Equivalent, Dec 17, 1993 |
| Received | Sep 21, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.