BCT SYSTEM

System, Multipurpose For In Vitro Coagulation Studies

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Bct System.

Pre-market Notification Details

Device IDK011665
510k NumberK011665
Device Name:BCT SYSTEM
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant DADE BEHRING, INC. P.O. BOX 6101 Newark,,  DE  19714
ContactRebecca S Ayash
CorrespondentRebecca S Ayash
DADE BEHRING, INC. P.O. BOX 6101 Newark,,  DE  19714
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-30
Decision Date2001-08-09
Summary:summary

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