Cleared Traditional

MODIFICATION TO DUET SYSTEM

K050840 · Bioview , Ltd. · Hematology
Aug 2005
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K050840 is an FDA 510(k) clearance for the MODIFICATION TO DUET SYSTEM, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Bioview , Ltd. (Ramat-Gan, IL). The FDA issued a Cleared decision on August 16, 2005, 137 days after receiving the submission on April 1, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K050840 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2005
Decision Date August 16, 2005
Days to Decision 137 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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