Cleared Traditional

CYTOVISION FOR CEP XY

K042542 · Applied Imaging Corp. · Hematology

Jan 2005

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K042542 is an FDA 510(k) clearance for the CYTOVISION FOR CEP XY, 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 January 10, 2005, 112 days after receiving the submission on September 20, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number	K042542 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2004
Decision Date	January 10, 2005
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Hematology (HE)
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