SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE…


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K111429
Device Name SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE…
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
JWY  
Subsequent Product Code
LRG  
Date Received 05/23/2011
Decision Date 08/18/2011
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