510(k) K212193 ยท FRC Indicator, Biological Sterilization Process
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
| Applicant | Plasmapp Co,., Ltd., Daejeon, KR |
| Decision | Substantially Equivalent, Oct 22, 2021 |
| Received | Jul 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212193
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.