510(k) K131508

Device

VYSIS D7S486/CEP 7 FISH PROBE KIT

Applicant

ABBOTT MOLECULAR, INC.

510(k) number

K131508

Product code

PFG  

Decision

Substantially Equivalent (SESE)

Decision date

2013-09-13

Date received

2013-05-24

Regulation

864.1870

Classification name

Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders

Medical specialty

Hematology

Review panel

Pathology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No