IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6


Device Classification Name

system, test, thyroid autoantibody

510(k) Number K991094
Device Name IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Applicant Contact edward m levine
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Correspodent Contact edward m levine
Regulation Number 866.5870
Classification Product Code
JZO  
Date Received 04/01/1999
Decision Date 05/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No