FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM— 510(k) K904795

Name: FDA 510(k) clearance K904795
Creator: U.S. Food and Drug Administration
Published: 1990-12-31

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K904795 for FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM, Substantially Equivalent on 1990-12-31. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GKH
Device class: Class 1
Regulation: 21 CFR 864.5240
Advisory panel: Hematology
Date received: 1990-10-19
Decision date: 1990-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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