Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K152579 |
FOIA Releasable 510(k) |
K152579
|
Device Name |
FilmArray Respiratory Panel EZ (RP EZ) |
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 | 09/10/2015 |
Decision Date | 10/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Dual Track
|
Reviewed by Third Party |
No
|
Combination Product |
No
|