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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Free Radical Assay, Morphine
510(k) Number K811637
Device Name RUBELLA LATEX CARD TEST
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 Number862.3640
Classification Product Code
DOK  
Date Received06/10/1981
Decision Date 08/13/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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