SENSITITRE VIZION


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K081520
Device Name SENSITITRE VIZION
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
982 keynote circle suite 6
cleveland, 
OH 
44131

Applicant Contact cynthia c knapp
Correspondent
TREK DIAGNOSTIC SYSTEMS, INC.
982 keynote circle suite 6
cleveland, 
OH 
44131

Correspodent Contact cynthia c knapp
Regulation Number 866.1640
Classification Product Code
JWY  
Date Received 05/30/2008
Decision Date 10/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No