Device Classification Name |
human metapneumovirus (hmpv) rna assay system
|
510(k) Number |
K112490 |
Device Name |
QUIDEL MOLECULAR 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 |
|
Date Received | 08/29/2011 |
Decision Date | 12/15/2011 |
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
|