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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 K883273
Device Name DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
Applicant
3M Company
3380 Central Expy.
Santa Clara,  CA  95051
Applicant Contact MONTE
Correspondent
3M Company
3380 Central Expy.
Santa Clara,  CA  95051
Correspondent Contact MONTE
Regulation Number866.5750
Classification Product Code
DHB  
Date Received08/03/1988
Decision Date 09/07/1988
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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