AUTOREADER 2


Device Classification Name

instrument for auto reader & interpretation of overnight suscept. systems

510(k) Number K103532
Device Name AUTOREADER 2
Applicant
TREK DIAGNOSTIC SYSTEMS
982 keynote circle
cleveland, 
OH 
44131

Applicant Contact cynthia knapp
Correspondent
TREK DIAGNOSTIC SYSTEMS
982 keynote circle
cleveland, 
OH 
44131

Correspodent Contact cynthia knapp
Regulation Number 866.1640
Classification Product Code
LRG  
Date Received 12/01/2010
Decision Date 08/26/2011
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