Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K123620 |
Device Name |
FILMARRAY RESPIRATORY PANEL (RP) |
Applicant |
BIOFIRE DIAGNOSTICS, INC. |
390 Wakara Way |
Salt Lake City,
UT
84108
|
|
Applicant Contact |
BETH LINGENFELTER |
Correspondent |
BIOFIRE DIAGNOSTICS, INC. |
390 Wakara Way |
Salt Lake City,
UT
84108
|
|
Correspondent Contact |
BETH LINGENFELTER |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/23/2012 |
Decision Date | 02/11/2013 |
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
|