Device Classification Name |
nucleic amplification assays for the detection of leishmania nucleic acids
|
510(k) Number |
K081868 |
Device Name |
SMART LEISH, MODEL LGM1-050 |
Applicant |
U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS |
1452 PORTER STREET |
FORT DETRICK,
MD
21702 -9232
|
|
Applicant Contact |
ROBER MILLER |
Correspondent |
U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS |
1452 PORTER STREET |
FORT DETRICK,
MD
21702 -9232
|
|
Correspondent Contact |
ROBER MILLER |
Regulation Number | 866.3870
|
Classification Product Code |
|
Date Received | 07/02/2008 |
Decision Date | 05/25/2011 |
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
|