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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 K950217
Device Name ORGENTEC THYROGLOBULIN 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 Received01/19/1995
Decision Date 04/24/1995
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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