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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 K871674
Device Name TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
Applicant
Organon Teknika Corp.
5516 Nicholson Ln.
Kensington,  TX  20895
Applicant Contact ROBERT WURZEL
Correspondent
Organon Teknika Corp.
5516 Nicholson Ln.
Kensington,  TX  20895
Correspondent Contact ROBERT WURZEL
Regulation Number866.1620
Classification Product Code
JTN  
Date Received04/29/1987
Decision Date 05/15/1987
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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