| Device Classification Name |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
More FDA Info for this Device |
| 510(K) Number |
K024152 |
| Device Name |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant |
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS, MD 21152-0999 US
Other 510(k) Applications for this Company
|
| Contact |
KATHRYN BABKA POWERS
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 |
12/17/2002 |
| Decision Date |
01/31/2003 |
| 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 |
|