DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM


Device Classification Name

system, test, rheumatoid factor

510(k) Number K021394
Device Name DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
Original Applicant
DIAMEDIX CORP.
2140 north miami ave.
miami, 
FL 
33127

Original Contact lynne stirling
Regulation Number 866.5775
Classification Product Code
DHR  
Date Received 05/02/2002
Decision Date 07/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No