510(k) K243343 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
BD CTGCTV2
| Applicant | Bd Integrated Diagnostic Solutions/Becton,, Sparks MD, US |
| Decision | Substantially Equivalent, Apr 22, 2025 |
| Received | Oct 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243343
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.