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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K973212
Device Name FRESH CELLS WI-38
Applicant
Diagnostic Hybrids, Inc.
One President St.
Athens,  OH  45701
Applicant Contact J. L. BROWN
Correspondent
Diagnostic Hybrids, Inc.
One President St.
Athens,  OH  45701
Correspondent Contact J. L. BROWN
Regulation Number864.2280
Classification Product Code
KIR  
Date Received08/27/1997
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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