Device Classification Name |
nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
|
510(k) Number |
K100287 |
Device Name |
JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 |
Applicant |
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND |
1430 VETERANS DRIVE |
FORT DETRICK,
MD
|
|
Applicant Contact |
ROBERT E MILLER |
Correspondent |
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND |
1430 VETERANS DRIVE |
FORT DETRICK,
MD
|
|
Correspondent Contact |
ROBERT E MILLER |
Regulation Number | 866.3332
|
Classification Product Code |
|
Date Received | 01/29/2010 |
Decision Date | 07/06/2010 |
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
|
|
|