510(k) K091960

Device

VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020

Applicant

ABBOTT MOLECULAR, INC.

510(k) number

K091960

Product code

OWK  

Decision

Substantially Equivalent (SESE)

Decision date

2011-08-29

Date received

2009-07-01

Regulation

866.6040

Classification name

Early Growth Response 1 (egr) Fish Probe Kit

Medical specialty

Immunology

Review panel

Pathology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No