510(k) K232545 ยท QUU Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
The SensiTox B. anthracis Toxin Test
| Applicant | First Light Diagnostics, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Nov 20, 2023 |
| Received | Aug 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232545
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.