RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11


Device Classification Name

antinuclear antibody (enzyme-labeled), antigen, controls

510(k) Number K992041
Device Name RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
Applicant
IMMUNO CONCEPTS, INC.
2280 springlake rd.
suite 106
dallas, 
TX 
75234

Applicant Contact eric s hoy
Correspondent
IMMUNO CONCEPTS, INC.
2280 springlake rd.
suite 106
dallas, 
TX 
75234

Correspodent Contact eric s hoy
Regulation Number 866.5100
Classification Product Code
LJM  
Date Received 06/17/1999
Decision Date 07/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No