510(k) K912387 ยท JGS Electrode, Ion Specific, Sodium
I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
| Applicant | I-Stat Corp., Princeton NJ, US |
| Decision | Substantially Equivalent, Jul 1, 1991 |
| Received | May 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT 6+ 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 key Terminated |
JPI | None listed |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT EC4+ 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 ke Terminated |
JPI | None listed |
| Jun 11, 2010 | Abbott Point of Care Inc. i-STAT E3+ 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 key Terminated |
JPI | None listed |
| 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 |
| 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 E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; 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.