XPERT C. DIFFICLE/EPI ASSAY


Device Classification Name

c. difficile nucleic acid amplification test assay

510(k) Number K110203
Device Name XPERT C. DIFFICLE/EPI ASSAY
Applicant
CEPHEID
904 caribbean drive
sunnyvale, 
CA 
94089 -1189

Applicant Contact russel k enns
Correspondent
CEPHEID
904 caribbean drive
sunnyvale, 
CA 
94089 -1189

Correspodent Contact russel k enns
Regulation Number 866.2660
Classification Product Code
OMN  
Date Received 01/24/2011
Decision Date 04/07/2011
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