510(k) K101234

Device

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

Applicant

VENTANA MEDICAL SYSTEMS, INC.

510(k) number

K101234

Product code

OWF  

Decision

Substantially Equivalent (SESE)

Decision date

2011-08-25

Date received

2010-05-03

Regulation

866.3110

Classification name

Immunohistochemical Assay, Helicobacter Pylori

Medical specialty

Microbiology

Review panel

Microbiology

Device class

1

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No