510(k) K171083 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
iChemVELOCITY Automated Urine Chemistry System
| Applicant | Iris Diagnostics, A Division of Iris International, Inc., Chatsworth CA, US |
| Decision | Substantially Equivalent, May 12, 2017 |
| Received | Apr 11, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171083
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.