ETI-EA-G ASSAY


Device Classification Name

epstein-barr virus, other

510(k) Number K992191
Device Name ETI-EA-G ASSAY
Applicant
DIASORIN, INC.
9175 guiford rd.
columbia, 
MD 
21046

Applicant Contact judith j smith
Regulation Number 866.3235
Classification Product Code
LSE  
Date Received 06/28/1999
Decision Date 07/12/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls