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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay (Two-Site Solid Phase), Ferritin
510(k) Number K781946
Device Name RIA KIT, FERRITIN SOLID PHASE
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 Number866.5340
Classification Product Code
JMG  
Date Received11/21/1978
Decision Date 01/10/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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