Cleared Traditional

DUET SYSTEM

K130775 · Bioview , Ltd. · Pathology

May 2014

Decision

415d

Days

Class 2

Risk

About This 510(k) Submission

K130775 is an FDA 510(k) clearance for the DUET SYSTEM, a System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays (Class II — Special Controls, product code NTH), submitted by Bioview , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on May 9, 2014, 415 days after receiving the submission on March 20, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number	K130775 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2013
Decision Date	May 09, 2014
Days to Decision	415 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	NTH — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.4700