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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 K863844
Device Name IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC
Applicant
Immuno Nuclear Corp.
1951 Northwestern Ave.
P.O. Bo 285
Stillwater,  MN  55082
Applicant Contact LISA J ANDERSEN
Correspondent
Immuno Nuclear Corp.
1951 Northwestern Ave.
P.O. Bo 285
Stillwater,  MN  55082
Correspondent Contact LISA J ANDERSEN
Regulation Number866.5750
Classification Product Code
DHB  
Date Received10/01/1986
Decision Date 10/29/1986
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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