Device Classification Name |
System, Blood Culturing
|
510(k) Number |
K121446 |
Device Name |
BACT/ALERT PF PLUS CULTURE BOTTLE |
Applicant |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Applicant Contact |
ELIZABETH LANDON |
Correspondent |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Correspondent Contact |
ELIZABETH LANDON |
Regulation Number | 866.2560
|
Classification Product Code |
|
Date Received | 05/15/2012 |
Decision Date | 01/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|