Device Classification Name |
2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
|
510(k) Number |
K101564 |
Device Name |
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL |
Applicant |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON RD., N.E. |
MAILSTOP C-12 |
ATLANTA,
GA
30333
|
|
Applicant Contact |
HYE-JOO KIM |
Correspondent |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON RD., N.E. |
MAILSTOP C-12 |
ATLANTA,
GA
30333
|
|
Correspondent Contact |
HYE-JOO KIM |
Regulation Number | 866.3332
|
Classification Product Code |
|
Date Received | 06/04/2010 |
Decision Date | 06/22/2010 |
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
|
|
|