HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM


Device Classification Name

system, test, radioallergosorbent (rast) immunological

510(k) Number K081217
Device Name HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
Applicant
HYCOR BIOMEDICAL, INC.
7272 chapman ave.
garden grove, 
CA 
92841

Applicant Contact p. narayan nayak
Correspondent
HYCOR BIOMEDICAL, INC.
7272 chapman ave.
garden grove, 
CA 
92841

Correspodent Contact p. narayan nayak
Regulation Number 866.5750
Classification Product Code
DHB  
Subsequent Product Code
DGC  
Date Received 04/30/2008
Decision Date 05/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No