510(k) K101947 ยท CGA Glucose Oxidase, Glucose
IVD-GE02
| Applicant | Sphere Medical , Ltd., Cambridge, GB |
| Decision | Substantially Equivalent, Mar 16, 2011 |
| Received | Jul 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101947
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.