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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, Indirect Immunofluorescent, Antigen, Control
510(k) Number K863717
Device Name ANTI-DNA MICROASSAY
Applicant
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Applicant Contact KIEFER, PHD
Correspondent
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Correspondent Contact KIEFER, PHD
Regulation Number866.5100
Classification Product Code
DHN  
Date Received09/23/1986
Decision Date 10/24/1986
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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