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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 K870870
Device Name AZTREONAM 30 MCG SUSCEPTIBILITY DISK
Applicant
Organon Teknika Corp.
800 Capitola Dr.
Durham,  NC  27713
Applicant Contact TONI M STIFANO
Correspondent
Organon Teknika Corp.
800 Capitola Dr.
Durham,  NC  27713
Correspondent Contact TONI M STIFANO
Regulation Number866.1620
Classification Product Code
JTN  
Date Received03/03/1987
Decision Date 03/17/1987
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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