IMMUNOCAP THYRLOBULIN IMMUNOCAP


Device Classification Name

immunochemical, thyroglobulin autoantibody

510(k) Number K072661
Device Name IMMUNOCAP THYRLOBULIN IMMUNOCAP
Applicant
PHADIA US INC.
4169 commercial ave.
portage, 
MI 
49002

Applicant Contact martin r mann
Correspondent
PHADIA US INC.
4169 commercial ave.
portage, 
MI 
49002

Correspodent Contact martin r mann
Regulation Number 866.5870
Classification Product Code
JNL  
Subsequent Product Codes
JJY   JZO  
Date Received 09/21/2007
Decision Date 11/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No