Cleared Traditional

CELLTRACKS AUTOPREP SYSTEM MODEL:9541

K100684 · Veridex, LLC · Hematology
Aug 2010
Decision
169d
Days
Class 1
Risk

About This 510(k) Submission

K100684 is an FDA 510(k) clearance for the CELLTRACKS AUTOPREP SYSTEM MODEL:9541, a Apparatus, Automated Blood Cell Diluting (Class I — General Controls, product code GKH), submitted by Veridex, LLC (Raritan, US). The FDA issued a Cleared decision on August 26, 2010, 169 days after receiving the submission on March 10, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5240.

Submission Details

510(k) Number K100684 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2010
Decision Date August 26, 2010
Days to Decision 169 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKH — Apparatus, Automated Blood Cell Diluting
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.5240

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