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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, All Types, Staphylococcus Spp.
510(k) Number K855236
Device Name DIAGNOSTIC REAGENT TST-RPLA
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
GTN  
Date Received12/31/1985
Decision Date 11/04/1986
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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