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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Netilmicin (I-125)
510(k) Number K833715
Device Name EMIT NETILMICIN ASSAY
Applicant
Syva Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Syva Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3450
Classification Product Code
LCE  
Date Received10/21/1983
Decision Date 12/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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