VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM


Device Classification Name

antinuclear antibody, indirect immunofluorescent, antigen, control

510(k) Number K022800
Device Name VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
Original Applicant
HYPERION, INC.
14100 s.w. 136th st.
miami, 
FL 
33186

Original Contact radha goolabsingh
Regulation Number 866.5100
Classification Product Code
DHN  
Date Received 08/23/2002
Decision Date 11/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No