ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM

Device Classification Name

system, test, rheumatoid factor

510(k) Number K033802
Device Name ATHENA MULTI-LITE RHEUMATOID FACTOR IGM 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 866.5775
Classification Product Code
DHR  
Date Received 12/08/2003
Decision Date 02/27/2004
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