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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C1q, Antigen, Antiserum, Control
510(k) Number K860996
Device Name SANASSAY IC TEST
Applicant
Scientific Sales Intl., Inc.
P.O. Box 1538
Kalamazoo,  MI  49005
Applicant Contact NICOLAS SCHMELZER
Correspondent
Scientific Sales Intl., Inc.
P.O. Box 1538
Kalamazoo,  MI  49005
Correspondent Contact NICOLAS SCHMELZER
Regulation Number866.5240
Classification Product Code
DAK  
Date Received03/11/1986
Decision Date 03/30/1987
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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