510(k) Number |
K170883 |
Device Name |
FilmArray NGDS Warrior Panel |
Applicant |
BioFire Defense, LLC |
79 West 4500 South, Suite 14 |
Salt Lake City,
UT
84107
|
|
Applicant Contact |
Cynthia Phillips |
Correspondent |
BioFire Defense, LLC |
79 West 4500 South, Suite 14 |
Salt Lake City,
UT
84107
|
|
Correspondent Contact |
Cynthia Phillips |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/24/2017 |
Decision Date | 06/22/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|