510(k) K122019

Device

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS

Applicant

MERIDIAN BIOSCIENCE, INC.

510(k) number

K122019

Product code

OYZ  

Decision

Substantially Equivalent (SESE)

Decision date

2012-09-13

Date received

2012-07-10

Regulation

866.3740

Classification name

Group A Streptococcus Nucleic Acid Amplification Assay System

Medical specialty

Microbiology

Review panel

Microbiology

Device class

1

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No