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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 K832307
Device Name ONPG DISCS
Applicant
Oxoid U.S.A., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Oxoid U.S.A., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2660
Classification Product Code
JTO  
Date Received07/14/1983
Decision Date 08/26/1983
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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