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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K042970
Device Name COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
Applicant
Copan Diagnostics, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA SINCLAIR
Correspondent
Copan Diagnostics, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA SINCLAIR
Regulation Number866.2390
Classification Product Code
JSM  
Date Received10/28/2004
Decision Date 12/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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