Cleared Traditional

ARIOL HER-2/NEU FISH

K043519 · Applied Imaging Corp. · Pathology

Apr 2005

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K043519 is an FDA 510(k) clearance for the ARIOL HER-2/NEU FISH, a System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays (Class II — Special Controls, product code NTH), submitted by Applied Imaging Corp. (San Jose, US). The FDA issued a Cleared decision on April 25, 2005, 126 days after receiving the submission on December 20, 2004. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number	K043519 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2004
Decision Date	April 25, 2005
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Statement

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