Cleared Traditional

VYSIS D7S486/CEP 7 FISH PROBE KIT

K131508 · Abbott Molecular, Inc. · Pathology

Sep 2013

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K131508 is an FDA 510(k) clearance for the VYSIS D7S486/CEP 7 FISH PROBE KIT, a Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders (Class II — Special Controls, product code PFG), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on September 13, 2013, 112 days after receiving the submission on May 24, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1870.

Submission Details

510(k) Number	K131508 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2013
Decision Date	September 13, 2013
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	PFG — Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.1870
Definition	Dna Fish Probe Kits For Specimen Characterization Detect Dna Probe Targets On Human Chromosomes In Bone Marrow And Peripheral Blood Specimens.