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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Supplement, Culture Media
510(k) Number K802753
Device Name CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.)
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 Number866.2450
Classification Product Code
JSK  
Date Received11/03/1980
Decision Date 12/11/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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