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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K900108
Device Name 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
Applicant
3M Company
3380 Central Expy.
Santa Clara,  CA  95051
Applicant Contact SYLVIA ZORICH
Correspondent
3M Company
3380 Central Expy.
Santa Clara,  CA  95051
Correspondent Contact SYLVIA ZORICH
Regulation Number866.5510
Classification Product Code
DGC  
Date Received01/09/1990
Decision Date 02/21/1990
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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