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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C5, Antigen, Antiserum, Control
510(k) Number K950102
Device Name HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
Applicant
Kent Laboratories, Inc.
23404 NE 8th St.
Redmond,  WA  98053
Applicant Contact DONALD A JORGENSEN
Correspondent
Kent Laboratories, Inc.
23404 NE 8th St.
Redmond,  WA  98053
Correspondent Contact DONALD A JORGENSEN
Regulation Number866.5240
Classification Product Code
DAY  
Date Received01/11/1995
Decision Date 04/10/1995
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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