ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT


Device Classification Name

nucleic acid amplification assay system, group b streptococcus, direct specimen test

510(k) Number K112125
Device Name ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati, 
OH 
45244

Applicant Contact susan d rolih
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati, 
OH 
45244

Correspodent Contact susan d rolih
Regulation Number 866.3740
Classification Product Code
NJR  
Date Received 07/25/2011
Decision Date 12/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No