Device Classification Name |
respiratory virus panel nucleic acid assay system
|
510(k) Number |
K160068 |
FOIA Releasable 510(k) |
K160068
|
Device Name |
FilmArray Respiratory Panel (RP) for use with FilmArray Torch |
Applicant |
BioFire Diagnostics, LLC |
390 Wakara Way |
Salt Lake City,
UT
84108
|
|
Applicant Contact |
KRISTEN J. KANACK |
Correspondent |
BioFire Diagnostics, LLC |
390 Wakara Way |
Salt Lake City,
UT
84108
|
|
Correspondent Contact |
KRISTEN J. KANACK |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/13/2016 |
Decision Date | 02/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|