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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 K821399
Device Name MACRO-VUE CARD TEST, NETILMICIN
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number862.3450
Classification Product Code
LCE  
Date Received05/11/1982
Decision Date 05/28/1982
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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