| Device Classification Name |
2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
|
|---|
| 510(K) Number |
K103766 |
|---|
| Model |
GXFLU-10, GX-I, GX-IV, GX-XVI,
|
| 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
|
|
| 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 (SE) |
|---|
| Classification Advisory Committee |
Microbiology
|
|---|
| Review Advisory Committee |
Microbiology
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
