Cleared Traditional

HEMOCUE WBC SYSTEM

K071652 · Hemocue AB · Hematology
Oct 2007
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K071652 is an FDA 510(k) clearance for the HEMOCUE WBC SYSTEM, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on October 25, 2007, 129 days after receiving the submission on June 18, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K071652 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2007
Decision Date October 25, 2007
Days to Decision 129 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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