CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)


Device Classification Name

system, test, radioallergosorbent (rast) immunological

510(k) Number K030590
Device Name CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 clyde ct.
mountain view, 
CA 
94043

Applicant Contact mary ann du brock
Correspondent
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 clyde ct.
mountain view, 
CA 
94043

Correspodent Contact mary ann du brock
Regulation Number 866.5750
Classification Product Code
DHB  
Date Received 02/25/2003
Decision Date 03/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No