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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staphylococcus Aureus Somatic Antigens
510(k) Number K874303
Device Name STAPHYLASE TEST
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 Number866.3700
Classification Product Code
LHT  
Date Received10/20/1987
Decision Date 11/06/1987
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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