Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K152523 |
Device Name |
JBAIDS Influenza A & B Detection Kit |
Applicant |
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY |
1430 VETERANS DRIVE |
FORT DETRICK,
MD
21702 -9232
|
|
Applicant Contact |
ROBERT E MILLER |
Correspondent |
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY |
1430 VETERANS DRIVE |
FORT DETRICK,
MD
21702 -9232
|
|
Correspondent Contact |
ROBERT E MILLER |
Regulation Number | 866.3980
|
Classification Product Code |
|
Date Received | 09/03/2015 |
Decision Date | 10/01/2015 |
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
|