Device Classification Name |
2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
|
510(k) Number |
K120911 |
Device Name |
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) |
Applicant |
CEPHEID |
904 CARIBBEAN DRIVE |
sunnyvale,
CA
94089 -1189
|
|
Applicant Contact |
kerry j flom |
Correspondent |
CEPHEID |
904 CARIBBEAN DRIVE |
sunnyvale,
CA
94089 -1189
|
|
Correspondent Contact |
kerry j flom |
Regulation Number | 866.3332
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/26/2012 |
Decision Date | 05/18/2012 |
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
|
|
|