Device Classification Name |
drug metabolizing enzyme genotyping systems
|
510(k) Number |
K093420 |
Device Name |
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) |
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 | 862.3360
|
Classification Product Code |
|
Date Received | 11/03/2009 |
Decision Date | 08/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|