Device Classification Name |
Parainfluenza Multiplex Nucleic Acid Assay
|
510(k) Number |
K141927 |
Device Name |
LYRA PARAINFLUENZA VIRUS ASSAY |
Applicant |
QUIDEL CORPORATION |
2005 E State St Suite 100 |
ATHENS,
OH
45701
|
|
Applicant Contact |
Ronald H Lollar |
Correspondent |
QUIDEL CORPORATION |
2005 E State St Suite 100 |
ATHENS,
OH
45701
|
|
Correspondent Contact |
Ronald H Lollar |
Regulation Number | 866.3980
|
Classification Product Code |
|
Date Received | 07/16/2014 |
Decision Date | 10/09/2014 |
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
|