Device Classification Name |
nucleic acid amplification assay system, group b streptococcus, direct specimen test
|
510(k) Number |
K121044 |
Device Name |
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM |
Applicant |
MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. |
CINCINNATI,
OH
45244
|
|
Applicant Contact |
Michelle L Smith |
Correspondent |
MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. |
CINCINNATI,
OH
45244
|
|
Correspondent Contact |
Michelle L Smith |
Regulation Number | 866.3740
|
Classification Product Code |
|
Date Received | 04/06/2012 |
Decision Date | 05/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|