510(k) K222921 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Minuteful-kidney test
| Applicant | Healthy.Io, Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Sep 8, 2023 |
| Received | Sep 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222921
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.