BEHRING COAGULATION TIMER

Plasma, Coagulation Control

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Coagulation Timer.

Pre-market Notification Details

Device IDK955278
510k NumberK955278
Device Name:BEHRING COAGULATION TIMER
ClassificationPlasma, Coagulation Control
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactKathleen Dray-lyons
CorrespondentKathleen Dray-lyons
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeGGN  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-17
Decision Date1996-05-30
Summary:summary

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