Device Classification Name |
Influenza A And Influenza B Multiplex Nucleic Acid Assay
|
510(k) Number |
K133869 |
Device Name |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT |
Applicant |
CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) |
1600 CLIFTON ROAD, MS-C18 |
ATLANTA,
GA
30333
|
|
Applicant Contact |
HYE-JOO KIM |
Correspondent |
CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) |
1600 CLIFTON ROAD, MS-C18 |
ATLANTA,
GA
30333
|
|
Correspondent Contact |
HYE-JOO KIM |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/20/2013 |
Decision Date | 01/17/2014 |
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
|
|
|