THYROGLOBULIN ANTIBODY ELISA


Device Classification Name

system, test, thyroid autoantibody

510(k) Number K960370
Device Name THYROGLOBULIN ANTIBODY ELISA
Applicant
IMMCO DIAGNOSTICS, INC.
963 kenmore ave.
buffalo, 
NY 
14223

Applicant Contact richard e greco
Correspondent
IMMCO DIAGNOSTICS, INC.
963 kenmore ave.
buffalo, 
NY 
14223

Correspodent Contact richard e greco
Regulation Number 866.5870
Classification Product Code
JZO  
Date Received 01/25/1996
Decision Date 06/20/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No