Device Classification Name |
C. Difficile Toxin Gene Amplification Assay
|
510(k) Number |
K163085 |
Device Name |
Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack |
Applicant |
Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC |
11331 Valley View Street |
Cypress,
CA
90630
|
|
Applicant Contact |
Irene M. Guzman |
Correspondent |
Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC |
11331 Valley View Street |
Cypress,
CA
90630
|
|
Correspondent Contact |
Irene M. Guzman |
Regulation Number | 866.3130
|
Classification Product Code |
|
Date Received | 11/03/2016 |
Decision Date | 02/14/2017 |
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
|
|
|