CELLTRACKS ANALYER II— 510(k) K113181

Substantially Equivalent

Veridex, LLC

FDA 510(k) clearance K113181 for CELLTRACKS ANALYER II, Substantially Equivalent on 2011-12-12. Applicant: Veridex, LLC. Device class: 2.

Clearance details

Applicant: Veridex, LLC
Product code: Code NQI
Device class: Class 2
Regulation: 21 CFR 866.6020
Advisory panel: Immunology
Date received: 2011-10-28
Decision date: 2011-12-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.