Cleared Traditional

ANEUVYSION

K972200 · Vysis · Pathology
Oct 1997
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K972200 is an FDA 510(k) clearance for the ANEUVYSION, a Dna-probe Kit, Human Chromosome (Class II — Special Controls, product code OYU), submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on October 20, 1997, 132 days after receiving the submission on June 10, 1997. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number K972200 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 1997
Decision Date October 20, 1997
Days to Decision 132 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code OYU — Dna-probe Kit, Human Chromosome
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.4700
Definition Detection Of Alpha Satellite Sequences In The Centromere Regions Of Human Chromosomes In Conjunction With Routine Diagnostic Cytgenetic Testing. It Is Indicated For Use As An Adjunct To Standard Cytogenetic Methaphase Analysis A Identifying And Enumerating Human Chromosomes Via Fluorescence In Situ Hybridization (fish) In Metaphase Cells And Interphase Nuclei Of Human Cells. It Is Not Intended To Be Used As A Stand Alone Assay For Test Reporting Or Clinical Diagnosis. Fish Results Are Intended To Be Reported And Interpreted Only In Conjunction With Results Of Standard Cytogenetic Analysis, Performed Concurrently, Utilizing The Same Patient Specimen.