510(k) K251035 · JOJ Indicator, Physical/Chemical Sterilization Process
DISINTEK PA Test Strips
| Applicant | Serim Research, Elkhart IN, US |
| Decision | Substantially Equivalent, Jun 3, 2025 |
| Received | Apr 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251035
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.