510(k) K810674 ยท CGA Glucose Oxidase, Glucose
GLUCOSE OXIDASE
| Applicant | Pointe Scientific, Inc.,, Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 31, 1981 |
| Received | Mar 12, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810674
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2009 | Pointe Scientific, Inc. Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Re Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.