510(k) K063486— BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY

Substantially Equivalent

Becton, Dickinson & CO

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code LON
Advisory panel: Microbiology
Date received: 2006-11-17
Decision date: 2007-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Adverse events under product code LON

product code LON

Malfunction: 2,383
Total: 2,383

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.