VIZION


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

Correspodent Contact cynthia c knapp
Regulation Number 866.1640
Classification Product Code
JWY  
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