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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 K863098
Device Name MEADOW FESCUE ALLERGEN DISC
Applicant
Immuno Nuclear Corp.
1951 Northwestern Ave.
P.O. Bo 285
Stillwater,  MN  55082
Applicant Contact GREG NELSON
Correspondent
Immuno Nuclear Corp.
1951 Northwestern Ave.
P.O. Bo 285
Stillwater,  MN  55082
Correspondent Contact GREG NELSON
Regulation Number866.5750
Classification Product Code
DHB  
Date Received08/13/1986
Decision Date 09/15/1986
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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