Device Classification Name |
system, test, automated, antimicrobial susceptibility, short incubation
|
510(k) Number |
K093224 |
Device Name |
DENSICHECK PLUS |
Applicant |
BIOMERIEUX, INC. |
595 ANGLUM RD. |
HAZELWOOD,
MO
63042
|
|
Applicant Contact |
JOLYN TENLLADO |
Correspondent |
BIOMERIEUX, INC. |
595 ANGLUM RD. |
HAZELWOOD,
MO
63042
|
|
Correspondent Contact |
JOLYN TENLLADO |
Regulation Number | 866.1645
|
Classification Product Code |
|
Date Received | 10/14/2009 |
Decision Date | 11/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|