510(k) K220345 ยท MLR Sterilizer, Chemical
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; 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, Apr 14, 2023 |
| Received | Feb 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220345
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.