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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Radiochemical Assay, Amikacin
510(k) Number K840647
Device Name AMIKACIN REAGENT TEST KIT
Applicant
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3035
Classification Product Code
LDN  
Date Received02/15/1984
Decision Date 04/02/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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