510(k) K060345 ยท CGA Glucose Oxidase, Glucose
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Apr 28, 2006 |
| Received | Feb 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060345
| 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 |
| Jun 10, 2010 | Nova Biomedical Corporation Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454.
Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care us 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.