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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 Powders, Antimicrobial
510(k) Number K860031
Device Name GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
Applicant
Organon Teknika Corp.
201 Tabor Rd.
Morris Plains,  NJ  07950
Applicant Contact LYNN DECARO
Correspondent
Organon Teknika Corp.
201 Tabor Rd.
Morris Plains,  NJ  07950
Correspondent Contact LYNN DECARO
Regulation Number866.1640
Classification Product Code
JTT  
Date Received01/06/1986
Decision Date 03/06/1986
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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