GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK


Device Classification Name

giardia spp.

510(k) Number K103673
Device Name GIARDIA/ CRYPTOSPORIDIUM 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 866.3220
Classification Product Code
MHI  
Subsequent Product Code
MHJ  
Date Received 12/16/2010
Decision Date 08/18/2011
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