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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K852268
Device Name QUANTICLONE IGE RADIOIMMUNASSAY
Applicant
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact SUSAN BIENIEK
Correspondent
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact SUSAN BIENIEK
Regulation Number866.5510
Classification Product Code
DGC  
Date Received05/28/1985
Decision Date 07/10/1985
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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