SENSITITRE AIM (TM)


Device Classification Name

reagent/device, inoculum calibration

510(k) Number K110331
Device Name SENSITITRE AIM (TM)
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
LIE  
Subsequent Product Codes
JWY   LRG  
Date Received 02/03/2011
Decision Date 04/27/2011
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