Device Classification Name |
system, blood culturing
|
510(k) Number |
K031737 |
Device Name |
BACT/ALERT MP CULTURE BOTTLES (PLASTIC) |
Applicant |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Applicant Contact |
JOCELYN JENNINGS |
Correspondent |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Correspondent Contact |
JOCELYN JENNINGS |
Regulation Number | 866.2560
|
Classification Product Code |
|
Date Received | 06/04/2003 |
Decision Date | 07/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|