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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, Systemic Lupus Erythematosus
510(k) Number K810226
Device Name SLE ANTI-N-DNA LATEX TEST
Applicant
Icl Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Icl Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5820
Classification Product Code
DHC  
Date Received01/27/1981
Decision Date 02/09/1981
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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