Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K081483 |
Device Name |
XTAG RESPIRATORY VIRAL PANEL |
Applicant |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. |
TORONTO, ONTARIO,
CA
M5G 1Y8
|
|
Applicant Contact |
GLORIA LEE |
Correspondent |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. |
TORONTO, ONTARIO,
CA
M5G 1Y8
|
|
Correspondent Contact |
GLORIA LEE |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/28/2008 |
Decision Date | 06/25/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|