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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K881379
Device Name WESBLOT RNP-SM TEST
Applicant
American Bionetics, Inc.
21377 Cabot Blvd.
Hayward,  CA  94545
Applicant Contact FRANK R RUDERMAN
Correspondent
American Bionetics, Inc.
21377 Cabot Blvd.
Hayward,  CA  94545
Correspondent Contact FRANK R RUDERMAN
Regulation Number866.5100
Classification Product Code
LKP  
Date Received04/01/1988
Decision Date 05/16/1988
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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