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
|
|
Correspondent Contact |
KERRY J FLOM |
Regulation Number | 866.3332
|
Classification Product Code |
|
Subsequent Product Codes |
|
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
|
|
|