Device Classification Name |
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
|
510(k) Number |
K130551 |
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 | 866.3332
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/04/2013 |
Decision Date | 05/22/2013 |
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
|
|
|