Cleared Traditional

DUET SYSTEM

K040591 · Bioview , Ltd. · Hematology
Sep 2004
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K040591 is an FDA 510(k) clearance for the DUET SYSTEM, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Bioview , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on September 16, 2004, 192 days after receiving the submission on March 8, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K040591 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2004
Decision Date September 16, 2004
Days to Decision 192 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOY — Device, Automated Cell-locating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5260

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