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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 K952130
Device Name ORGENTEC ANTI-TG ELISA
Applicant
American Laboratory Products Co., Ltd.
7 Colchester Rd.
Windham,  NH  03087
Applicant Contact RICHARD E CONLEY
Correspondent
American Laboratory Products Co., Ltd.
7 Colchester Rd.
Windham,  NH  03087
Correspondent Contact RICHARD E CONLEY
Regulation Number866.5870
Classification Product Code
JZO  
Date Received05/08/1995
Decision Date 06/20/1995
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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