FACSMATE SAMPLE HANDLING DEVICE— 510(k) K885132

Name: FDA 510(k) clearance K885132
Creator: U.S. Food and Drug Administration
Published: 1988-12-28

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K885132 for FACSMATE SAMPLE HANDLING DEVICE, Substantially Equivalent on 1988-12-28. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1988-12-12
Decision date: 1988-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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