VIDAS RUB IGG


Device Classification Name

enzyme linked immunoabsorbent assay, rubella

510(k) Number K080766
Device Name VIDAS RUB IGG
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Applicant Contact nikita s mapp
Correspondent
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Correspodent Contact nikita s mapp
Regulation Number 866.3510
Classification Product Code
LFX  
Date Received 03/18/2008
Decision Date 12/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No