510(k) K151589 ยท OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
BD MAX CT/GC/TV, BD MAX INSTRUMENT
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, Sep 6, 2016 |
| Received | Jun 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max CT/GC/TV;
Catalog # 442970 Terminated |
OUY | None listed |
| Jul 18, 2017 | Becton Dickinson & Co. BD MAX" CT/GC/TV.
Catalog Number(s):
443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and femal Terminated |
NSU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.