ZEUS ELISA HSV GG-2 IGG TEST SYSTEM


Device Classification Name

enzyme linked immunosorbent assay, herpes simplex virus, hsv-2

510(k) Number K103603
Device Name ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
200 evans way
branchburg, 
NJ 
08876

Applicant Contact ewa nadolczak
Correspondent
ZEUS SCIENTIFIC, INC.
200 evans way
branchburg, 
NJ 
08876

Correspodent Contact ewa nadolczak
Regulation Number 866.3305
Classification Product Code
MYF  
Date Received 12/08/2010
Decision Date 05/20/2011
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