510(k) K051034 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
URYXXON 200 URINE ANALYZER
| Applicant | Macherey-Nagel GmbH & Co. KG, Rockville MD, US |
| Decision | Substantially Equivalent, Nov 22, 2005 |
| Received | Apr 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051034
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.