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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K960702
Device Name CRP-LATEX SEIKEN XR REAGENT SYSTEM
Applicant
Globe Management Support, Inc.
12-1 Nihonbashi, Kabuto-Cho
Chuo-Ku, Tokyo 103,  JP
Applicant Contact TERRENCE T LEE
Correspondent
Globe Management Support, Inc.
12-1 Nihonbashi, Kabuto-Cho
Chuo-Ku, Tokyo 103,  JP
Correspondent Contact TERRENCE T LEE
Regulation Number866.5270
Classification Product Code
DCK  
Date Received02/20/1996
Decision Date 04/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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