K173523 is an FDA 510(k) clearance for the BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL). This device is classified as a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II - Special Controls, product code LON).
Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on February 9, 2018, 87 days after receiving the submission on November 14, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.
| 510(k) Number | K173523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2017 |
| Decision Date | February 09, 2018 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1645 |