Device Classification Name |
system, blood culturing
|
510(k) Number |
K120994 |
Device Name |
BD BACTEC PLUS PRIME AEROBIC/F |
Applicant |
Becton, Dickinson and Company |
7 LOVETON CIRCLE, MC 614 |
SPARKS,
MD
21152
|
|
Applicant Contact |
Paul Swift |
Correspondent |
Becton, Dickinson and Company |
7 LOVETON CIRCLE, MC 614 |
SPARKS,
MD
21152
|
|
Correspondent Contact |
Paul Swift |
Regulation Number | 866.2560
|
Classification Product Code |
|
Date Received | 04/02/2012 |
Decision Date | 08/07/2012 |
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
|
|
|