Cleared Traditional

DUET SYSTEM

K061602 · Bioview , Ltd. · Hematology
Jan 2007
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K061602 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. (Tel Aviv, IL). The FDA issued a Cleared decision on January 23, 2007, 229 days after receiving the submission on June 8, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K061602 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2006
Decision Date January 23, 2007
Days to Decision 229 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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