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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K962052
Device Name ORGENTEC ABTI-SS-BB(LA) ELISA
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 Number866.5100
Classification Product Code
LJM  
Date Received05/28/1996
Decision Date 11/15/1996
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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