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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent/Device, Inoculum Calibration
510(k) Number K890339
Device Name DIFCO DIRECTOR INOCULATION SYSTEM
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 Number866.1640
Classification Product Code
LIE  
Date Received01/23/1989
Decision Date 02/07/1989
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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