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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 K850607
Device Name AMDINOCILLIN 10 MCG SENSITIVITY DISCS
Applicant
DIFCO LABORATORIES, INC.
P.O. BOX 331058
detroit,  MI  48232 -7058
Applicant Contact robert
Correspondent
DIFCO LABORATORIES, INC.
P.O. BOX 331058
detroit,  MI  48232 -7058
Correspondent Contact robert
Regulation Number866.1620
Classification Product Code
JTN  
Date Received02/15/1985
Decision Date 03/20/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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