Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K112199 |
Device Name |
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) |
Applicant |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. |
SUITE 900 |
TORONTO, ONTARIO,
CA
M5G 1Y8
|
|
Applicant Contact |
LUBNA SYED |
Correspondent |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. |
SUITE 900 |
TORONTO, ONTARIO,
CA
M5G 1Y8
|
|
Correspondent Contact |
LUBNA SYED |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/01/2011 |
Decision Date | 09/01/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|