Device Classification Name |
Instrumentation For Clinical Multiplex Test Systems
|
510(k) Number |
K070597 |
Device Name |
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR 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 | 862.2570
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/02/2007 |
Decision Date | 10/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|