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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, Antigen, Control
510(k) Number K914550
Device Name ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
Applicant
Diagnostic Resources, Inc.
13898 E. Greenwood Dr.
Aurora,  CO  80014
Applicant Contact BARBARA L WESTRICK
Correspondent
Diagnostic Resources, Inc.
13898 E. Greenwood Dr.
Aurora,  CO  80014
Correspondent Contact BARBARA L WESTRICK
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received10/11/1991
Decision Date 02/11/1992
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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