Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K092957 |
Device Name |
VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST |
Applicant |
NANOSPHERE, INC |
4088 COMMERCIAL AVENUE |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
GREGORY SHIPP |
Correspondent |
NANOSPHERE, INC |
4088 COMMERCIAL AVENUE |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
GREGORY SHIPP |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/25/2009 |
Decision Date | 10/21/2009 |
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
|
|
|