Device Classification Name |
system, test, automated, antimicrobial susceptibility, short incubation
|
510(k) Number |
K031984 |
Device Name |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML |
Applicant |
BECTON, DICKINSON & CO. |
7 LOVETON CIR. |
SPARKS,
MD
21152 -0999
|
|
Applicant Contact |
KATHRYN BABKA POWERS |
Correspondent |
BECTON, DICKINSON & CO. |
7 LOVETON CIR. |
SPARKS,
MD
21152 -0999
|
|
Correspondent Contact |
KATHRYN BABKA POWERS |
Regulation Number | 866.1645
|
Classification Product Code |
|
Date Received | 06/26/2003 |
Decision Date | 08/27/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|