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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Selective And Non-Differential
510(k) Number K862946
Device Name OXOID SIGNAL BLOOD CULTURE SYSTEM
Applicant
Oxoid U.S.A., Inc.
Wade Rd. Basingstroke
Hampshire Rg 24 Op,  GB
Applicant Contact E. Y BRIDSON
Correspondent
Oxoid U.S.A., Inc.
Wade Rd. Basingstroke
Hampshire Rg 24 Op,  GB
Correspondent Contact E. Y BRIDSON
Regulation Number866.2300
Classification Product Code
JSG  
Date Received08/05/1986
Decision Date 11/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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