Device Classification Name |
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
|
510(k) Number |
K160462 |
Device Name |
FilmArray Meningitis/Encephalitis (ME) Panel 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 | 866.3970
|
Classification Product Code |
|
Date Received | 02/19/2016 |
Decision Date | 03/17/2016 |
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
|
|
|