MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT


Device Classification Name

herpes simplex virus nucleic acid amplification assay

510(k) Number K111527
Device Name MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
Applicant
ERAGEN BIOSCIENCES, INC.
918 deming way, suite 201
madison, 
WI 
53717 -1944

Applicant Contact david lim
Correspondent
ERAGEN BIOSCIENCES, INC.
918 deming way, suite 201
madison, 
WI 
53717 -1944

Correspodent Contact david lim
Regulation Number 866.3305
Classification Product Code
OQO  
Date Received 06/01/2011
Decision Date 08/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No