DIRECTIGEN NEISSERIA MENINGITIDIS TEST— 510(k) K920274

Name: FDA 510(k) clearance K920274
Creator: U.S. Food and Drug Administration
Published: 1992-03-18

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K920274 for DIRECTIGEN NEISSERIA MENINGITIDIS TEST, Substantially Equivalent on 1992-03-18. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GTI
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1992-01-22
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cockeysville, MD, US

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