SHIGA TOXIN QUIK CHEK


Device Classification Name

antigens, all types, escherichia coli

510(k) Number K121364
Device Name SHIGA TOXIN QUIK CHEK
Applicant
TECHLAB INC., CORPORATE RESEARCH CENTER
2001 kraft dr.
blacksburg, 
VA 
24060 -6358

Applicant Contact donna t link
Correspondent
TECHLAB INC., CORPORATE RESEARCH CENTER
2001 kraft dr.
blacksburg, 
VA 
24060 -6358

Correspodent Contact donna t link
Regulation Number 866.3255
Classification Product Code
GMZ  
Date Received 05/07/2012
Decision Date 10/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No