IMMULITE 2000 ALLERGEN-SPECIFIC IGE


Device Classification Name

system, test, radioallergosorbent (rast) immunological

510(k) Number K023152
Device Name IMMULITE 2000 ALLERGEN-SPECIFIC IGE
Original Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Original Contact edward m levine
Regulation Number 866.5750
Classification Product Code
DHB  
Date Received 09/23/2002
Decision Date 12/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No