Device Classification Name |
bordetella pertussis dna assay system
|
510(k) Number |
K173498 |
Device Name |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
Applicant |
DiaSorin Molecular LLC |
11331 Valley View Street |
Cypress,
CA
90630
|
|
Applicant Contact |
Sharon Young |
Correspondent |
DiaSorin Molecular LLC |
11331 Valley View Street |
Cypress,
CA
90630
|
|
Correspondent Contact |
Sharon Young |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/13/2017 |
Decision Date | 08/13/2018 |
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
|
|
|