510(k) K193490 ยท LLH Reagents, Clostridium Difficile Toxin
SensiTox C. difficile Toxin Test
| Applicant | First Light Diagnostics, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Jul 8, 2021 |
| Received | Dec 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193490
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.