VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY


Device Classification Name

reagents, clostridium difficile toxin

510(k) Number K080931
Device Name VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
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 866.2660
Classification Product Code
LLH  
Date Received 04/02/2008
Decision Date 06/11/2008
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