DeviceClearance

K173523

Substantially Equivalent

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

Applicant
Becton, Dickinson and Company
Product code
LON
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sparks, MD, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LON

product code LON
Malfunction
2,383
Total
2,383

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.