510(k) K070960 ยท CGA Glucose Oxidase, Glucose
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Jul 11, 2007 |
| Received | Apr 5, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070960
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.