ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM

Device Classification Name

system, test, thyroid autoantibody

510(k) Number K033977
Device Name ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
200 evans way
branchburg, 
NJ 
08876

Applicant Contact mark j kopnitsky
Correspondent
ZEUS SCIENTIFIC, INC.
200 evans way
branchburg, 
NJ 
08876

Correspodent Contact mark j kopnitsky
Regulation Number 866.5870
Classification Product Code
JZO  
Date Received 12/23/2003
Decision Date 03/22/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No