Device Classification Name |
System, Blood Culturing
|
510(k) Number |
K954468 |
Device Name |
MB/BACT MYCROBACTERIA DETECTION SYSTEM |
Applicant |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Applicant Contact |
ANN M QUINN |
Correspondent |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Correspondent Contact |
ANN M QUINN |
Regulation Number | 866.2560
|
Classification Product Code |
|
Date Received | 09/26/1995 |
Decision Date | 07/22/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|