510(k) K200970 ยท FRC Indicator, Biological Sterilization Process
Self-Contained Biological Indicator
| Applicant | True Indicating, LLC, Toledo OH, US |
| Decision | Substantially Equivalent, Dec 28, 2020 |
| Received | Apr 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200970
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.