510(k) K193514 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
AUTION MAX AX-4060 Urinalysis System
| Applicant | Arkray, Inc., Kamigyo-Ku, JP |
| Decision | Substantially Equivalent, Apr 13, 2023 |
| Received | Dec 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193514
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.