510(k) K210585 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
BD CTGCTV2
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, May 10, 2022 |
| Received | Feb 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2024 | Becton Dickinson & Co. BD COR MX Instrument
Version or Model: 443989
Catalog Number: 443989 Open, Classified |
QEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.