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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lectins And Protectins
510(k) Number K792583
Device Name GAMMA ARACHIS HYPOGEA LECTIN
Applicant
Gamma Biologicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gamma Biologicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.9550
Classification Product Code
KSI  
Date Received12/14/1979
Decision Date 01/16/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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