510(k) K023885 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
COMBI-SCREEN, MODELS 10SL AND 11SL
| Applicant | Analyticon Biotechnologies AG, Deer Field IL, US |
| Decision | Substantially Equivalent, Oct 21, 2003 |
| Received | Nov 21, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023885
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.