Device Classification Name |
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
More FDA Info for this Device |
510(K) Number |
K061686 |
Device Name |
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
Applicant |
GENEOHM SCIENCES CANADA, INC.
PO BOX 103
BALDWIN, MD 21082 US
Other 510(k) Applications for this Company
|
Contact |
Judi Smith
Other 510(k) Applications for this Contact |
Regulation Number |
866.1640
More FDA Info for this Regulation Number |
Classification Product Code |
NIJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/15/2006 |
Decision Date |
08/30/2006 |
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 |
|