Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
More FDA Info for this Device |
510(K) Number |
K112424 |
Device Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
Applicant |
NANOSPHERE, INC
4088 COMMERCIAL AVENUE
NORTHBROOK, IL 60062 US
Other 510(k) Applications for this Company
|
Contact |
MARK DEL VECCHIO
Other 510(k) Applications for this Contact |
Regulation Number |
866.1640
More FDA Info for this Regulation Number |
Classification Product Code |
NQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/23/2011 |
Decision Date |
12/16/2011 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
MI - Microbiology |
Review Advisory Committee |
MI - Microbiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|