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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 K855206
Device Name CEFACLOR 30 MCG SENSITIVITY DISCS
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Applicant Contact ROBERT
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Correspondent Contact ROBERT
Regulation Number866.1620
Classification Product Code
JTN  
Date Received12/30/1985
Decision Date 01/24/1986
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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