DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT— 510(k) K882629

Name: FDA 510(k) clearance K882629
Creator: U.S. Food and Drug Administration
Published: 1988-10-31

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K882629 for DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT, Substantially Equivalent on 1988-10-31. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1988-06-27
Decision date: 1988-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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