Device Classification Name |
C. Difficile Toxin Gene Amplification Assay
|
510(k) Number |
K170491 |
Device Name |
Solana C. difficile 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 | 866.3130
|
Classification Product Code |
|
Date Received | 02/17/2017 |
Decision Date | 05/11/2017 |
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
|
|
|