BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML— 510(k) K032153

Substantially Equivalent

Bd Diagnostic Systems

FDA 510(k) clearance K032153 for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML, Substantially Equivalent on 2003-09-11. Applicant: Bd Diagnostic Systems.

Clearance details

Applicant: Bd Diagnostic Systems
Product code: Code LON
Advisory panel: Microbiology
Date received: 2003-07-14
Decision date: 2003-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

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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.