Device Classification Name |
nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
|
510(k) Number |
K080570 |
Device Name |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL |
Applicant |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON RD.,MS-C12 |
ATLANTA,
GA
30333
|
|
Applicant Contact |
STEPHEN LINDSTROM |
Correspondent |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON RD.,MS-C12 |
ATLANTA,
GA
30333
|
|
Correspondent Contact |
STEPHEN LINDSTROM |
Regulation Number | 866.3332
|
Classification Product Code |
|
Date Received | 02/29/2008 |
Decision Date | 09/30/2008 |
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
|
|
|