Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K181289 |
Device Name |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System |
Applicant |
Cepheid |
904 Caribbean Drive |
Sunnyvale,
CA
94089
|
|
Applicant Contact |
Yi-Ping Lin |
Correspondent |
Cepheid |
904 Caribbean Drive |
Sunnyvale,
CA
94089
|
|
Correspondent Contact |
Jim Kelly |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/16/2018 |
Decision Date | 08/15/2018 |
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
|
|
|