ClearanceBrief
510(k) K251035 · JOJ Indicator, Physical/Chemical Sterilization Process

DISINTEK™ PA Test Strips

ApplicantSerim Research, Elkhart IN, US
DecisionSubstantially Equivalent, Jun 3, 2025
ReceivedApr 3, 2025
TypeTraditional
FDA recordOpen 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.