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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name susceptibility test discs, antimicrobial
510(k) Number K860153
Device Name OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
Applicant
OXOID U.S.A., INC.
WADE RD. BASINGSTROKE
HAMPSHIRE RG 24 OP,  GB
Applicant Contact E. Y BRIDSON
Correspondent
OXOID U.S.A., INC.
WADE RD. BASINGSTROKE
HAMPSHIRE RG 24 OP,  GB
Correspondent Contact E. Y BRIDSON
Regulation Number866.1620
Classification Product Code
JTN  
Date Received01/15/1986
Decision Date 03/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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