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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, Anticardiolipin Immunological
510(k) Number K962926
Device Name ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
Applicant
American Laboratory Products Co., Ltd.
P.O. Box 451
Windham,  NH  03087
Applicant Contact RICHARD CONLEY
Correspondent
American Laboratory Products Co., Ltd.
P.O. Box 451
Windham,  NH  03087
Correspondent Contact RICHARD CONLEY
Regulation Number866.5660
Classification Product Code
MID  
Date Received07/29/1996
Decision Date 10/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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