SENSITITRE OPTIREAD


Device Classification Name

instrument for auto reader & interpretation of overnight suscept. systems

510(k) Number K110583
Device Name SENSITITRE OPTIREAD
Applicant
TREK DIAGNOSTIC SYSTEMS, LTD.
982 keynote circle
suite 6
cleveland, 
OH 
44131

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

Correspodent Contact cynthia c knapp
Regulation Number 866.1640
Classification Product Code
LRG  
Date Received 03/01/2011
Decision Date 09/22/2011
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