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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ceruloplasmin, Antigen, Antiserum, Control
510(k) Number K860138
Device Name NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
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 Number866.5210
Classification Product Code
DDB  
Date Received01/14/1986
Decision Date 03/28/1986
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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