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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ceruloplasmin, Antigen, Antiserum, Control
510(k) Number K850682
Device Name 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
Applicant
Kent Laboratories, Inc.
23404 NE 8th St.
Redmond,  WA  98053
Applicant Contact ALLAN H JORGENSEN
Correspondent
Kent Laboratories, Inc.
23404 NE 8th St.
Redmond,  WA  98053
Correspondent Contact ALLAN H JORGENSEN
Regulation Number866.5210
Classification Product Code
DDB  
Date Received02/21/1985
Decision Date 11/25/1985
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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