Device Classification Name |
Trichomonas Vaginalis Nucleic Acid Amplification Test System
|
510(k) Number |
K143329 |
Device Name |
AmpliVue Trichomonas Assay |
Applicant |
QUIDEL CORPORATION |
2005 EAST STATE STREET |
SUITE 100 |
ATHENS,
OH
45701
|
|
Applicant Contact |
RONALD H LOLLAR |
Correspondent |
QUIDEL CORPORATION |
2005 EAST STATE STREET |
SUITE 100 |
ATHENS,
OH
45701
|
|
Correspondent Contact |
RONALD H LOLLAR |
Regulation Number | 866.3860
|
Classification Product Code |
|
Date Received | 11/20/2014 |
Decision Date | 03/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|