RF-LATEX SEIKEN REAGENT SYSTEM

System, Test, Rheumatoid Factor

GLOBE MANAGEMENT SUPPORT, INC.

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

Pre-market Notification Details

Device IDK960703
510k NumberK960703
Device Name:RF-LATEX SEIKEN REAGENT SYSTEM
ClassificationSystem, Test, Rheumatoid Factor
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 CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-20
Decision Date1996-04-19
Summary:summary

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