Device Classification Name |
antisera, fluorescent, human metapneumovirus
|
510(k) Number |
K093233 |
Device Name |
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT |
Applicant |
DIAGNOSTIC HYBRIDS, INC. |
1055 EAST STATE STREET |
SUITE 100 |
ATHENS,
OH
45701
|
|
Applicant Contact |
Ronald H Lollar |
Correspondent |
DIAGNOSTIC HYBRIDS, INC. |
1055 EAST STATE STREET |
SUITE 100 |
ATHENS,
OH
45701
|
|
Correspondent Contact |
Ronald H Lollar |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/14/2009 |
Decision Date | 12/04/2009 |
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
|
|
|