RHEUMATOID FACTOR (RF)


Device Classification Name

system, test, rheumatoid factor

510(k) Number K024067
Device Name RHEUMATOID FACTOR (RF)
Original Applicant
ABBOTT LABORATORIES
1920 hurd dr.
irving, 
TX 
75038

Original Contact linda morris
Regulation Number 866.5775
Classification Product Code
DHR  
Date Received 12/10/2002
Decision Date 01/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No