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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K844887
Device Name IDENTIFICATION STICKS OXIDASE
Applicant
Oxoid U.S.A., Inc.
9017 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact RUTH KEMP
Correspondent
Oxoid U.S.A., Inc.
9017 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact RUTH KEMP
Regulation Number866.2660
Classification Product Code
JTO  
Date Received12/17/1984
Decision Date 02/25/1985
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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