CRP-LATEX SEIKEN XR REAGENT SYSTEM

C-reactive Protein, Antigen, Antiserum, And Control

GLOBE MANAGEMENT SUPPORT, INC.

The following data is part of a premarket notification filed by Globe Management Support, Inc. with the FDA for Crp-latex Seiken Xr Reagent System.

Pre-market Notification Details

Device IDK960702
510k NumberK960702
Device Name:CRP-LATEX SEIKEN XR REAGENT SYSTEM
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant GLOBE MANAGEMENT SUPPORT, INC. 12-1 NIHONBASHI, KABUTO-CHO Chuo-ku, Tokyo 103,  JP
ContactTerrence T Lee
CorrespondentTerrence T Lee
GLOBE MANAGEMENT SUPPORT, INC. 12-1 NIHONBASHI, KABUTO-CHO Chuo-ku, Tokyo 103,  JP
Product CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-20
Decision Date1996-04-19
Summary:summary

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