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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amikacin Serum Assay
510(k) Number K790899
Device Name BACTEC
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 Number862.3035
Classification Product Code
KLP  
Date Received05/09/1979
Decision Date 05/23/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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