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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Types, Escherichia Coli
510(k) Number K990263
Device Name IMMUNOCARD STAT! E. COLI O157:H7
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact ALLEN D NICKOL
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact ALLEN D NICKOL
Regulation Number866.3255
Classification Product Code
GMZ  
Date Received01/27/1999
Decision Date 08/09/1999
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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