IBD-QUIK CHEK


Device Classification Name

lactoferrin, antigen, antiserum, control

510(k) Number K030704
Device Name IBD-QUIK CHEK
Applicant
TECHLAB, INC.
1861 pratt dr., ste. 1030
blacksburg, 
VA 
24060 -6364

Applicant Contact david m lyerly
Correspondent
TECHLAB, INC.
1861 pratt dr., ste. 1030
blacksburg, 
VA 
24060 -6364

Correspodent Contact david m lyerly
Regulation Number 866.5570
Classification Product Code
DEG  
Date Received 03/06/2003
Decision Date 04/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No