Device Classification Name |
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
|
510(k) Number |
K142501 |
Device Name |
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
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 |
SCOTT A. CAMPBELL |
Regulation Number | 866.3990
|
Classification Product Code |
|
Date Received | 09/05/2014 |
Decision Date | 11/26/2014 |
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
|
|
|