CMV LATEX AGGLUTINATION TEST KIT— 510(k) K841520

Name: FDA 510(k) clearance K841520
Creator: U.S. Food and Drug Administration
Published: 1984-09-07

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K841520 for CMV LATEX AGGLUTINATION TEST KIT, Substantially Equivalent on 1984-09-07. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LJO
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1984-04-12
Decision date: 1984-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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