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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Antigen, Antiserum, Control
510(k) Number K855009
Device Name QUANTIMETRIC PLUS IGA 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 Number866.5510
Classification Product Code
CZP  
Date Received12/16/1985
Decision Date 02/26/1986
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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