Cleared Traditional

CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

K022512 · Immunicon Corp. · Hematology
Sep 2002
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K022512 is an FDA 510(k) clearance for the CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518, 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 September 30, 2002, 62 days after receiving the submission on July 30, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5240.

Submission Details

510(k) Number K022512 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2002
Decision Date September 30, 2002
Days to Decision 62 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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