| Device Classification Name |
dna-reagents, neisseria
|
|---|
| 510(K) Number |
K121710 |
|---|
| Models |
900-0453,-0454,-0455,-0456,-0457,
CT/NGURINE-50; CT/NGSWAB-50,
GX-I 900-0423; GX-IV 900-0425, -0424, -0433, -0400, GX-XVI: 900-0429,-0427,-0726,
GXCT/NG-10
|
| Device Name |
XPERT CT/NG |
|---|
| Applicant |
| CEPHEID |
| 904 caribbean drive |
|
sunnyvale,
CA
94089
|
|
| Contact |
russel k enns |
| Regulation Number | 866.3390
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 06/11/2012 |
|---|
| Decision Date | 12/27/2012 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| 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
|
|---|
|
|
