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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K820029
Device Name KALLESTAD RAST REAGENTS
Applicant
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5750
Classification Product Code
DHB  
Date Received01/05/1982
Decision Date 04/06/1982
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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