510(k) K936081 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
I-STAT TESTS FOR ACID-BASE PARAMETERS
| Applicant | I-Stat Corp., Ontario K2l 1t9, Canada, CA |
| Decision | Substantially Equivalent, Feb 24, 1994 |
| Received | Dec 21, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.