ALPCO MILENIA ANTI-TG EIA


Device Classification Name

system, test, thyroid autoantibody

510(k) Number K011415
Device Name ALPCO MILENIA ANTI-TG EIA
Original Applicant
AMERICAN LABORATORY PRODUCTS CO., LTD.
p.o. box 451
windham, 
NH 
03087

Original Contact richard e conley
Regulation Number 866.5870
Classification Product Code
JZO  
Date Received 05/08/2001
Decision Date 05/30/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No