CELLTRACKS AUTOPREP SYSTEM MODEL:9541— 510(k) K100684

Name: FDA 510(k) clearance K100684
Creator: U.S. Food and Drug Administration
Published: 2010-08-26

Substantially Equivalent

Veridex, LLC

FDA 510(k) clearance K100684 for CELLTRACKS AUTOPREP SYSTEM MODEL:9541, Substantially Equivalent on 2010-08-26. Applicant: Veridex, LLC. Device class: 1.

Clearance details

Applicant: Veridex, LLC
Product code: Code GKH
Device class: Class 1
Regulation: 21 CFR 864.5240
Advisory panel: Hematology
Date received: 2010-03-10
Decision date: 2010-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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