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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
Recalls CDRH Recalls
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