510(k) K880585 ยท CGA Glucose Oxidase, Glucose
DEXPAD, BLOOD GLUCOSE STRIP
| Applicant | Mach Diag. C/O Wichita State University, Wichita KS, US |
| Decision | Substantially Equivalent, Apr 18, 1988 |
| Received | Feb 10, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880585
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.