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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bence-Jones Protein, Antigen, Antiserum, Control
510(k) Number K802284
Device Name ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
Applicant
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5150
Classification Product Code
CZQ  
Date Received09/19/1980
Decision Date 10/23/1980
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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