510(k) K895526 ยท CGA Glucose Oxidase, Glucose
COBAS READY GLUCOSE REAGENT
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Oct 16, 1989 |
| Received | Sep 12, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895526
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.