510(k) K061812 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
| Applicant | Analyticon Biotechnologies AG, Lichtenfels, Hessen, DE |
| Decision | Substantially Equivalent, Apr 6, 2007 |
| Received | Jun 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061812
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.