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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 K852394
Device Name MDCK
Applicant
Viromed Laboratories, Inc.
5100 Gamble Dr.
Suite 55
Minneapolis,  MN  55416
Applicant Contact BONITA L BASKIN
Correspondent
Viromed Laboratories, Inc.
5100 Gamble Dr.
Suite 55
Minneapolis,  MN  55416
Correspondent Contact BONITA L BASKIN
Regulation Number864.2280
Classification Product Code
KIR  
Date Received06/06/1985
Decision Date 07/12/1985
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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