510(k) K200533 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
binx io CT/NG Assay and binx io CT/NG System
| Applicant | Binx Health, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Apr 27, 2020 |
| Received | Mar 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2023 | Binx Health, Inc. binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae
Ref: 1.002.101 Open, Classified |
QEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.