510(k) K191352 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
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| Applicant | Binx Health, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Aug 8, 2019 |
| Received | May 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191352
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.