510(k) K001387 ยท CGA Glucose Oxidase, Glucose
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
| Applicant | I-Stat Corp., East Windsor NJ, US |
| Decision | Substantially Equivalent, Oct 5, 2000 |
| Received | May 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2012 | Abbott Point Of Care Inc. iStat1 Analyzer
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the Terminated |
CHL | None listed |
| Jul 9, 2012 | Abbott Point Of Care Inc. i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analy Terminated |
CHL | None listed |
| Jul 9, 2012 | Abbott Point Of Care Inc. Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of Terminated |
CHL | None listed |
| Jul 9, 2012 | Abbott Point Of Care Inc. i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Terminated |
CHL | None listed |
| Jul 9, 2012 | Abbott Point Of Care Inc. i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as por Terminated |
CHL | None listed |
| Jul 9, 2012 | Abbott Point Of Care Inc. Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 2 Terminated |
CHL | None listed |
| Dec 10, 2010 | Abbott Point Of Care Inc. i-STAT Portable Clinical Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat Terminated |
CGA | None listed |
| Dec 10, 2010 | Abbott Point Of Care Inc. Military Kit Portable Clinical Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the Terminated |
CGA | None listed |
| Sep 23, 2010 | Abbott Point of Care Inc. GCX Mountable Downloader-Recharger;
(accessory to the i-STAT Portable Clinical Analyzer (model 300).
The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mou Terminated |
CGA | None listed |
| Mar 15, 2010 | Abbott Point of Care Inc. Martel Printer
The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical Terminated |
CGA | None listed |
| Feb 26, 2010 | Abbott Point of Care Inc. i-STAT HL7 Interface
The HL7 Interface product is an accessory to the analyzer Terminated |
JQP | None listed |
| Feb 24, 2010 | Abbott Point of Care Inc. i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA.
The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and M Terminated |
CGA | None listed |
| Sep 30, 2009 | Abbott Point of Care Inc. Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack.
Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.