EBV EA-D IGG ELISA KIT, MODEL EBG-100


Device Classification Name

epstein-barr virus, other

510(k) Number K021793
Device Name EBV EA-D IGG ELISA KIT, MODEL EBG-100
Original Applicant
PAN BIO PTY. LTD.
116 lutwyche rd.
windsor
brisbane, queensland, 

AU

4030

Original Contact helen jennings
Regulation Number 866.3235
Classification Product Code
LSE  
Date Received 05/31/2002
Decision Date 09/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No