ClearanceBrief
510(k) K251800 · JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

Healgen® URS Test Strips

ApplicantHealgen Scientific,, LLC, Houston TX, US
DecisionSubstantially Equivalent, Dec 23, 2025
ReceivedJun 12, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251800

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.