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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Immunoassay, Igg
510(k) Number K854483
Device Name KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
Applicant
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact QUINLAN SMITH
Correspondent
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact QUINLAN SMITH
Regulation Number866.5530
Classification Product Code
KTO  
Date Received11/07/1985
Decision Date 12/11/1985
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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