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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 K841930
Device Name ENZYMATIC ACETAMINOPHEN ASSAY
Applicant
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Regulation Number866.5100
Classification Product Code
LKP  
Date Received05/10/1984
Decision Date 06/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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