Cleared Traditional

IMMUNICON CELLTRACKS AUTOPREP SYSTEM

K040077 · Immunicon Corp. · Hematology
Mar 2004
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K040077 is an FDA 510(k) clearance for the IMMUNICON CELLTRACKS AUTOPREP SYSTEM, a Apparatus, Automated Blood Cell Diluting (Class I — General Controls, product code GKH), submitted by Immunicon Corp. (Huntingdon Valley, US). The FDA issued a Cleared decision on March 12, 2004, 58 days after receiving the submission on January 14, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5240.

Submission Details

510(k) Number K040077 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2004
Decision Date March 12, 2004
Days to Decision 58 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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