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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
510(k) Number K951967
Device Name HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
Applicant
KENT LABORATORIES, INC.
23404 N.E. 8TH ST.
REDMOND,  WA  98053
Applicant Contact DONALD A JORGENSEN
Correspondent
KENT LABORATORIES, INC.
23404 N.E. 8TH ST.
REDMOND,  WA  98053
Correspondent Contact DONALD A JORGENSEN
Regulation Number866.5250
Classification Product Code
DBA  
Date Received04/27/1995
Decision Date 05/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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