Device Classification Name |
system, test, automated, antimicrobial susceptibility, short incubation
|
510(k) Number |
K033362 |
Device Name |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE |
Applicant |
BECTON DICKINSON & CO. |
7 LOVETON CIR. |
SPARKS,
MD
21152
|
|
Applicant Contact |
MICHELLE B BANDY |
Correspondent |
BECTON DICKINSON & CO. |
7 LOVETON CIR. |
SPARKS,
MD
21152
|
|
Correspondent Contact |
MICHELLE B BANDY |
Regulation Number | 866.1645
|
Classification Product Code |
|
Date Received | 10/21/2003 |
Decision Date | 04/09/2004 |
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
|
|
|