Device Classification Name |
respiratory virus panel nucleic acid assay system
|
510(k) Number |
K143080 |
Device Name |
FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System |
Applicant |
BioFire Diagnostics, LLC |
390 Wakara Way |
Salt Lake City,
UT
84108
|
|
Applicant Contact |
Kristen Kanack |
Correspondent |
BioFire Diagnostics, LLC |
390 Wakara Way |
Salt Lake City,
UT
84108
|
|
Correspondent Contact |
Kristen Kanack |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/27/2014 |
Decision Date | 02/17/2015 |
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
|