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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, Enriched
510(k) Number K884208
Device Name LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
Applicant
Oxoid U.S.A., Inc.
9017 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact MARYALICE FRANCISCO
Correspondent
Oxoid U.S.A., Inc.
9017 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact MARYALICE FRANCISCO
Regulation Number866.2330
Classification Product Code
KZI  
Date Received10/06/1988
Decision Date 10/25/1988
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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