Cleared Traditional

COULTER CELLPREP

K021150 · Beckman Coulter, Inc. · Hematology
Jun 2002
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K021150 is an FDA 510(k) clearance for the COULTER CELLPREP, a Apparatus, Automated Blood Cell Diluting (Class I — General Controls, product code GKH), submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on June 11, 2002, 62 days after receiving the submission on April 10, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5240.

Submission Details

510(k) Number K021150 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2002
Decision Date June 11, 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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