ClearanceBrief
510(k) K232103 · QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator

Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

ApplicantTerragene S.A., Alvear, AR
DecisionSubstantially Equivalent, Apr 5, 2024
ReceivedJul 14, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K232103

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.