Device Classification Name |
Human Metapneumovirus (Hmpv) Rna Assay System
|
510(k) Number |
K122189 |
Device Name |
QUIDEL MOLECULAR RSV + HMPV ASSAY |
Applicant |
QUIDEL CORP. |
10165 MCKELLAR CT. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
Ronald H Lollar |
Correspondent |
QUIDEL CORP. |
10165 MCKELLAR CT. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
Ronald H Lollar |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/24/2012 |
Decision Date | 03/08/2013 |
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
|