Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
|
510(k) Number |
K112424 |
Device Name |
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) |
Applicant |
NANOSPHERE, INC |
4088 COMMERCIAL AVENUE |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
MARK DEL VECCHIO |
Correspondent |
NANOSPHERE, INC |
4088 COMMERCIAL AVENUE |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
MARK DEL VECCHIO |
Regulation Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/23/2011 |
Decision Date | 12/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|