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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K896398
Device Name DIFCO OXIDASE DRYSLIDE
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 Number866.2660
Classification Product Code
JTO  
Date Received11/06/1989
Decision Date 12/18/1989
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
Recalls CDRH Recalls
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