Device Classification Name |
System, Blood Culturing
|
510(k) Number |
K915796 |
Device Name |
BACTEC 9240 SYSTEM |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
33 MANSELL COURT |
P.O. BOX 337 |
ROSWELL,
GA
30077
|
|
Applicant Contact |
FRANK J SWENSON |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
33 MANSELL COURT |
P.O. BOX 337 |
ROSWELL,
GA
30077
|
|
Correspondent Contact |
FRANK J SWENSON |
Regulation Number | 866.2560
|
Classification Product Code |
|
Date Received | 12/24/1991 |
Decision Date | 04/22/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|