SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

Instrument, Coagulation, Automated

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Sysmex Automated Coagulation Analyzer, Model Ca-6000.

Pre-market Notification Details

Device IDK001145
510k NumberK001145
Device Name:SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
ClassificationInstrument, Coagulation, Automated
Applicant DADE BEHRING, INC. 7739 NW 48 ST. SUITE 120 Miami,  FL  33166
ContactRadames Riesgo
CorrespondentRadames Riesgo
DADE BEHRING, INC. 7739 NW 48 ST. SUITE 120 Miami,  FL  33166
Product CodeGKP  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-10
Decision Date2000-05-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.