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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prealbumin, Antigen, Antiserum, Control
510(k) Number K951966
Device Name HUMAN PREALBUMIN 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 Number866.5060
Classification Product Code
JZJ  
Date Received04/27/1995
Decision Date 06/01/1995
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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