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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C4, Antigen, Antiserum, Control
510(k) Number K772247
Device Name COMPLEMENT C4 NEPHELOMETRIC ASSAY
Applicant
Kallestad Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kallestad Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5240
Classification Product Code
DBI  
Date Received12/09/1977
Decision Date 12/22/1977
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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