Device Classification Name |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
More FDA Info for this Device |
510(K) Number |
K121863 |
Device Name |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Applicant |
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM, NC 27712 US
Other 510(k) Applications for this Company
|
Contact |
ELIZABETH LANDON
Other 510(k) Applications for this Contact |
Regulation Number |
866.1645
More FDA Info for this Regulation Number |
Classification Product Code |
LON
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/26/2012 |
Decision Date |
08/16/2012 |
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 |
|