Device Classification Name |
Manual Antimicrobial Susceptibility Test Systems
|
510(k) Number |
K112276 |
Device Name |
VIZION |
Applicant |
TREK DIAGNOSTIC SYSTEMS |
982 KEYNOTE CIRCLE |
CLEVELAND,
OH
44131
|
|
Applicant Contact |
CYNTHIA C KNAPP |
Correspondent |
TREK DIAGNOSTIC SYSTEMS |
982 KEYNOTE CIRCLE |
CLEVELAND,
OH
44131
|
|
Correspondent Contact |
CYNTHIA C KNAPP |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 08/09/2011 |
Decision Date | 11/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|