Device Classification Name |
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
|
510(k) Number |
K070804 |
Device Name |
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST |
Applicant |
NANOSPHERE, INC |
4088 COMMERCIAL AVENUE |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
SUE KENT |
Correspondent |
NANOSPHERE, INC |
4088 COMMERCIAL AVENUE |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
SUE KENT |
Regulation Number | 862.3360
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/23/2007 |
Decision Date | 09/17/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|