LEUCO PREP— 510(k) K854093

Name: FDA 510(k) clearance K854093
Creator: U.S. Food and Drug Administration
Published: 1985-11-12

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K854093 for LEUCO PREP, Substantially Equivalent on 1985-11-12. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JCF
Device class: Class 1
Regulation: 21 CFR 864.8500
Advisory panel: Hematology
Date received: 1985-10-07
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

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