Device Classification Name |
System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies
More FDA Info for this Device |
510(K) Number |
K091766 |
Device Name |
System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies |
Applicant |
BINAX, INC.
10 SOUTHGATE RD.
SCARBOROUGH, ME 04074 US
Other 510(k) Applications for this Company
|
Contact |
SUZANNE M VOGEL
Other 510(k) Applications for this Contact |
Regulation Number |
866.1640
More FDA Info for this Regulation Number |
Classification Product Code |
MYI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/17/2009 |
Decision Date |
02/24/2010 |
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 |
|