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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, Carcinoembryonic Antigen
510(k) Number K810810
Device Name AMICON ULTRAFILTRATION MEMBRANES CMII
Applicant
Amicon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Amicon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.6010
Classification Product Code
DHX  
Date Received03/24/1981
Decision Date 04/17/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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