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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Febrile (Weil-Felix), All Groups
510(k) Number K760881
Device Name FEBRILE ANTIGEN CONTROL SERA
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 Number866.3410
Classification Product Code
GSZ  
Date Received10/21/1976
Decision Date 11/09/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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