510(k) K160062 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
AUTION ELEVEN Semi-Automated Urinalysis System
| Applicant | Arkray, Inc., Kamigyo-Ku, JP |
| Decision | Substantially Equivalent, Oct 7, 2016 |
| Received | Jan 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160062
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.