Device Classification Name |
system, blood culturing
|
510(k) Number |
K973325 |
Device Name |
BACT/ALERT FAN CULTURE BOTTLES |
Applicant |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Applicant Contact |
REBECCA A RIVAS |
Correspondent |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Correspondent Contact |
REBECCA A RIVAS |
Regulation Number | 866.2560
|
Classification Product Code |
|
Date Received | 09/04/1997 |
Decision Date | 12/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|