Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
More FDA Info for this Device |
510(K) Number |
K142721 |
Device Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
Applicant |
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
PLEASANTON, CA 94588-2722 US
Other 510(k) Applications for this Company
|
Contact |
Wilk von Gustedt
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 |
09/23/2014 |
Decision Date |
12/17/2014 |
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 |
|