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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 K843251
Device Name RD CELLS
Applicant
VIROMED LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VIROMED LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.2280
Classification Product Code
KIR  
Date Received08/20/1984
Decision Date 09/06/1984
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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