Device Classification Name |
influenza a and influenza b multiplex nucleic acid assay
|
510(k) Number |
K153148 |
Device Name |
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping |
Applicant |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) |
1600 CLIFTON ROAD, MS-C18 |
ATLANTA,
GA
30329 -4027
|
|
Applicant Contact |
YON YU |
Correspondent |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) |
1600 CLIFTON ROAD, MS-C18 |
ATLANTA,
GA
30329 -4027
|
|
Correspondent Contact |
YON YU |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/30/2015 |
Decision Date | 12/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|