Device Classification Name |
Influenza A And Influenza B Multiplex Nucleic Acid Assay
|
510(k) Number |
K140857 |
Device Name |
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
Applicant |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON ROAD, MS-C18 |
ATLANTA,
GA
30333
|
|
Applicant Contact |
CDR YON YU, PHARM.D. |
Correspondent |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON ROAD, MS-C18 |
ATLANTA,
GA
30333
|
|
Correspondent Contact |
CDR YON YU, PHARM.D. |
Regulation Number | 866.3980
|
Classification Product Code |
|
Date Received | 04/03/2014 |
Decision Date | 04/25/2014 |
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
|
|
|