510(k) K223023 ยท FRC Indicator, Biological Sterilization Process
Terragene Bionava 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, May 9, 2023 |
| Received | Sep 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223023
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.