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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 K971585
Device Name IMMUNOCARD STAT! ROTAVIRUS
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 Number866.3405
Classification Product Code
LIQ  
Date Received05/01/1997
Decision Date 08/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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