Device Classification Name |
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
More FDA Info for this Device |
510(K) Number |
K123753 |
Device Name |
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
Applicant |
INTELLIGENT MEDICAL DEVICES, INC
180 CABOT ST.
BEVERLY, MA 01915 US
Other 510(k) Applications for this Company
|
Contact |
FRAN WHITE
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 |
12/06/2012 |
Decision Date |
07/17/2013 |
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 |
|