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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 K874115
Device Name NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
Applicant
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact LEO BRESSLER
Correspondent
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact LEO BRESSLER
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received10/09/1987
Decision Date 11/04/1987
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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