510(k) K253863 · FKJ Filter, Blood, Dialysis
GUARDIAN Quick Dip Residual Chlorine (5212)
| Applicant | Serim Research, Elkhart IN, US |
| Decision | Substantially Equivalent, Mar 17, 2026 |
| Received | Dec 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253863
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.