510(k) K191021 ยท FRC Indicator, Biological Sterilization Process
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
| Applicant | Terragene S.A., Alvear, AR |
| Decision | Substantially Equivalent, Sep 13, 2019 |
| Received | Apr 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191021
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2024 | TERRAGENE S.A. Terragene Integron IT26-C
Terragene Integron IT26-C with extender
Benco Dental Chemical Integrator [5726-583]
Tuttnauer (WTL198-0082)
Terragene Integron (PCD26-C)
Terragene Bionova PCD (PCD222-C) Open, Classified |
JOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.