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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 K860895
Device Name CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
Applicant
Organon Teknika Corp.
201 Tabor Rd.
Morris Plains,  NJ  07950
Applicant Contact VIVIAN DEVITA
Correspondent
Organon Teknika Corp.
201 Tabor Rd.
Morris Plains,  NJ  07950
Correspondent Contact VIVIAN DEVITA
Regulation Number866.1620
Classification Product Code
JTN  
Date Received03/10/1986
Decision Date 04/11/1986
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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