| Device Classification Name |
nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
|
|---|
| 510(K) Number |
K060159 |
|---|
| Device Name |
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET |
|---|
| Applicant |
| CENTERS FOR DISEASE CONTROL AND PREVENTION |
| 1600 clifton rd. ne (ms c-12) |
|
atlanta,
GA
30333
|
|
| Contact |
hye-joo kim |
| Regulation Number | 866.3332
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 01/20/2006 |
|---|
| Decision Date | 02/03/2006 |
|---|
| Decision |
de novo petitions granted (AN) |
|---|
| Classification Advisory Committee |
Microbiology
|
|---|
| Review Advisory Committee |
Microbiology
|
|---|
| FOI Item |
Approval Letter
|
| FDA Review |
Decision Summary
|
|---|
| Type |
De Novo Petitions Granted
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
