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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K862313
Device Name KALLESTAD SM/RNP TEST REAGENT
Applicant
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact KATIA BRESLAWEC
Correspondent
Kallestad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact KATIA BRESLAWEC
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received06/18/1986
Decision Date 08/06/1986
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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