HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200


Device Classification Name

system, test, radioallergosorbent (rast) immunological

510(k) Number K080322
Device Name HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
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  
Date Received 02/06/2008
Decision Date 03/05/2008
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