IMMULITE 2000 MIXED ALLERGEN PANELS


Device Classification Name

system, test, radioallergosorbent (rast) immunological

510(k) Number K021208
Device Name IMMULITE 2000 MIXED ALLERGEN PANELS
Original Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Original Contact robert m di tullio
Regulation Number 866.5750
Classification Product Code
DHB  
Date Received 04/16/2002
Decision Date 05/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No