Device Classification Name |
System, Blood Culturing
|
510(k) Number |
K935711 |
Device Name |
BACT/ALERT FAN AEROBIC CULTURE BOTTLE |
Applicant |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Applicant Contact |
THOMAS S CLEMENT |
Correspondent |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Correspondent Contact |
THOMAS S CLEMENT |
Regulation Number | 866.2560
|
Classification Product Code |
|
Date Received | 11/30/1993 |
Decision Date | 08/30/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|