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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Types, Escherichia Coli
510(k) Number K953362
Device Name PREMIER EHEC
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
GNA  
Date Received07/17/1995
Decision Date 11/14/1995
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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