Cleared Traditional

IMMUNICON CELLTRACKS ANALYZER

K030263 · Immunicon Corp. · Hematology
Nov 2003
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K030263 is an FDA 510(k) clearance for the IMMUNICON CELLTRACKS ANALYZER, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Immunicon Corp. (Huntingdon Valley, US). The FDA issued a Cleared decision on November 24, 2003, 301 days after receiving the submission on January 27, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K030263 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2003
Decision Date November 24, 2003
Days to Decision 301 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220