510(k) K181427 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BD MAX Enteric Viral Panel, BD MAX Instrument
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, Nov 29, 2018 |
| Received | Jun 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max Enteric Viral Panel EU
Catalog # 443985 Terminated |
PCH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.