ZEUS ELISA HSV GC-I IGG TEST SYSTEM


Device Classification Name

enzyme linked immunosorbent assay, herpes simplex virus, hsv-1

510(k) Number K103363
Device Name ZEUS ELISA HSV GC-I 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
MXJ  
Date Received 11/17/2010
Decision Date 04/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No