XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0


Device Classification Name

2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification

510(k) Number K103766
Device Name XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
Applicant
CEPHEID
904 caribbean drive
sunnyvale, 
CA 
94089 -1189

Applicant Contact kerry j flom
Correspondent
CEPHEID
904 caribbean drive
sunnyvale, 
CA 
94089 -1189

Correspodent Contact kerry j flom
Regulation Number 866.3332
Classification Product Code
OQW  
Subsequent Product Codes
OCC   OOI  
Date Received 12/23/2010
Decision Date 04/21/2011
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

Recalls CDRH Recalls