Cleared Traditional

ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000

K080909 · Ikonisys, Inc. · Pathology

Oct 2008

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K080909 is an FDA 510(k) clearance for the ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000, a System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays (Class II — Special Controls, product code NTH), submitted by Ikonisys, Inc. (New Haven, US). The FDA issued a Cleared decision on October 17, 2008, 199 days after receiving the submission on April 1, 2008. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number	K080909 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2008
Decision Date	October 17, 2008
Days to Decision	199 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