510(k) K963535 ยท CGA Glucose Oxidase, Glucose
SIGMA DIAGNOSTICS GLUCOSE REAGENT
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jan 17, 1997 |
| Received | Sep 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963535
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.