510(k) K063821 ยท CGA Glucose Oxidase, Glucose
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Jan 24, 2007 |
| Received | Dec 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063821
| 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 |
| Apr 19, 2013 | Nova Biomedical Corporation Nova StatStrip Xpress Glu-Test Strips (Glucose test strips)
Catalog # 42214 Terminated |
CGA | None listed |
| Apr 19, 2013 | Nova Biomedical Corporation Nova StatStrip Xpress Glu-Test Strips (Glucose test strips)
Catalog # 51493 (UK Only) 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.