Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
More FDA Info for this Device |
510(K) Number |
K071026 |
Device Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
Applicant |
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
6146 NANCY RIDGE DRIVE
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
|
Contact |
RAYMOND BOULE
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 |
04/11/2007 |
Decision Date |
12/20/2007 |
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 |
|