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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Thyroid Autoantibody
510(k) Number K950089
Device Name ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)
Applicant
American Laboratory Products Co., Ltd.
P.O. Box 451
Windham,  NH  03087
Applicant Contact RICHARD E CONLEY
Correspondent
American Laboratory Products Co., Ltd.
P.O. Box 451
Windham,  NH  03087
Correspondent Contact RICHARD E CONLEY
Regulation Number866.5870
Classification Product Code
JZO  
Date Received01/10/1995
Decision Date 04/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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