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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 K943891
Device Name RD CULTURE CELL
Applicant
NEOGENEX
12811 EIGHT AVENUE WEST
SUITE A-101
EVERETT,  WA  98204
Applicant Contact WILLIAM E RADANY
Correspondent
NEOGENEX
12811 EIGHT AVENUE WEST
SUITE A-101
EVERETT,  WA  98204
Correspondent Contact WILLIAM E RADANY
Regulation Number864.2280
Classification Product Code
KIR  
Date Received08/09/1994
Decision Date 11/28/1994
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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