ClearanceBrief
510(k) DEN220042 ยท QVB Biological Sterilization Indicator With Indirect Growth Detection

Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

ApplicantTerragene S.A., Alvear, AR
DecisionUnknown, Jul 12, 2024
ReceivedJul 1, 2022
TypeDirect
FDA recordOpen on fda.gov

Recalls that name DEN220042

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.