HERPESELECT 2 ELISA IGG, MODEL ELO920G


Device Classification Name

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

510(k) Number K021486
Device Name HERPESELECT 2 ELISA IGG, MODEL ELO920G
Original Applicant
FOCUS TECHNOLOGIES, INC.
10703 progress way
cypress, 
CA 
90630 -4737

Original Contact michael j wagner
Regulation Number 866.3305
Classification Product Code
MXJ  
Date Received 05/03/2002
Decision Date 08/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No