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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 K870152
Device Name ALLERGEN SPECIFIC CONTROLS
Applicant
3M Company
1500 Salado Dr.
Mountain View,  CA  94043
Applicant Contact ALEXANDER MONTE
Correspondent
3M Company
1500 Salado Dr.
Mountain View,  CA  94043
Correspondent Contact ALEXANDER MONTE
Regulation Number866.5750
Classification Product Code
DHB  
Date Received01/13/1987
Decision Date 02/06/1987
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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