Device Classification Name |
Influenza A And Influenza B Multiplex Nucleic Acid Assay
|
510(k) Number |
K132508 |
Device Name |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
Applicant |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON RD., N.E. |
MAILSTOP C-18 |
ATLANTA,
GA
30333
|
|
Applicant Contact |
HYE-JOO KIM, PHARM.D. |
Correspondent |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON RD., N.E. |
MAILSTOP C-18 |
ATLANTA,
GA
30333
|
|
Correspondent Contact |
HYE-JOO KIM, PHARM.D. |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/12/2013 |
Decision Date | 09/23/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|