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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 -7058
Applicant Contact ROBERT
Correspondent
DIFCO LABORATORIES, INC.
P.O. BOX 331058
DETROIT,  MI  48232 -7058
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
Recalls CDRH Recalls
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