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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rotavirus
510(k) Number K884017
Device Name ROTACUBE
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 Number866.3405
Classification Product Code
LIQ  
Date Received09/22/1988
Decision Date 01/24/1989
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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