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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 K885065
Device Name IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)
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 Received12/06/1988
Decision Date 01/04/1989
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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