510(k) K070068 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, May 7, 2007 |
| Received | Jan 8, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2014 | Nova Biomedical Corporation Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter,
Rechargeable Lithium Batteries
Single: 46626; 4 Pack: Terminated |
CGA | None listed |
| Sep 23, 2008 | Nova Biomedical Corporation Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215)
Used with:
Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and Terminated |
CGA | None listed |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2
P/N 9600, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | None listed |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | None listed |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.