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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 K851561
Device Name WI-38 GENCELLS
Applicant
GENUS DIAGNOSTICS
225 WILDWOOD ST.
WOBURN,  MA  01801
Applicant Contact PETER J MIONE
Correspondent
GENUS DIAGNOSTICS
225 WILDWOOD ST.
WOBURN,  MA  01801
Correspondent Contact PETER J MIONE
Regulation Number864.2280
Classification Product Code
KIR  
Date Received04/16/1985
Decision Date 05/10/1985
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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