DIRECTIGEN MENINGITIS COMBO TEST KIT— 510(k) K915330

Name: FDA 510(k) clearance K915330
Creator: U.S. Food and Drug Administration
Published: 1992-03-23

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K915330 for DIRECTIGEN MENINGITIS COMBO TEST KIT, Substantially Equivalent on 1992-03-23. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GTJ
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1991-11-26
Decision date: 1992-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

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