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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 K935336
Device Name CYNOMOLOGUS MONKEY KIDNEY CELLS
Applicant
Advanced Clinical Diagnostics
1021 Broadway
Toledo,  OH  43609
Applicant Contact P.S. THOMBRE, PH.D
Correspondent
Advanced Clinical Diagnostics
1021 Broadway
Toledo,  OH  43609
Correspondent Contact P.S. THOMBRE, PH.D
Regulation Number864.2280
Classification Product Code
KIR  
Date Received11/05/1993
Decision Date 01/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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