COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM

Instrument, Coagulation

ZYCARE

The following data is part of a premarket notification filed by Zycare with the FDA for Coagcare Anticoagulation Management System.

Pre-market Notification Details

Device IDK050821
510k NumberK050821
Device Name:COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
ClassificationInstrument, Coagulation
Applicant ZYCARE 3804 SWEETEN CREEK RD. Chapel Hill,  NC  27514
ContactSteve D Holdaway
CorrespondentSteve D Holdaway
ZYCARE 3804 SWEETEN CREEK RD. Chapel Hill,  NC  27514
Product CodeKQG  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-31
Decision Date2005-08-16
Summary:summary

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