510(k) K801897 ยท CGA Glucose Oxidase, Glucose
GLUCOSE DIAGNOSTIC REAGENT
| Applicant | Connecticut Diagnostics, Ltd., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 10, 1980 |
| Received | Aug 8, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801897
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.