Device Classification Name |
manual antimicrobial susceptibility test systems
|
510(k) Number |
K153569 |
Device Name |
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml |
Applicant |
LIOFILCHEM S.R.L |
64026 ROSETO DEGLI |
ABRUZZI,
IT
|
|
Applicant Contact |
Fabio Brocco |
Correspondent |
LABORATORY SPECIALISTS, INC |
1651-A CROSSINGS PARKWAY |
WESTLAKE,
OH
44145
|
|
Correspondent Contact |
LAURA M. KOETH |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 12/15/2015 |
Decision Date | 06/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|