BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR— 510(k) K854064

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K854064 for BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR, Substantially Equivalent on 1985-10-23. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KZI
Advisory panel: Microbiology
Date received: 1985-10-04
Decision date: 1985-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

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Adverse events under product code KZI

product code KZI

Malfunction: 2,834
Total: 2,834

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.