510(k) K140111 ยท PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, May 6, 2014 |
| Received | Jan 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max Enteric Bacterial Panel EU;
Catalog # 442963 Terminated |
PCH | None listed |
| Jan 14, 2019 | Becton Dickinson & Co. BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System
Catalog Number: 442963
The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro di Terminated |
PIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.