Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K163628 |
Device Name |
Idylla Respiratory (IFV-RSV) Panel |
Applicant |
JANSSEN PHARMACEUTICA NV |
TURNHOUTSEWEG 30 |
BEERSE,
BE
2340
|
|
Applicant Contact |
SARAH PARSONS |
Correspondent |
JANSSEN RESEARCH & DEVELOPMENT LLC |
920 US HIGHWAY 202 |
RARITAN,
NJ
08869
|
|
Correspondent Contact |
SARAH PARSONS |
Regulation Number | 866.3980
|
Classification Product Code |
|
Date Received | 12/22/2016 |
Decision Date | 08/30/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02786381
|
Reviewed by Third Party |
No
|
Combination Product |
No
|