THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES

System, Multipurpose For In Vitro Coagulation Studies

HAEMOSCOPE CORP.

The following data is part of a premarket notification filed by Haemoscope Corp. with the FDA for Thrombelastograph Coagulation Analyzer Teg-5000 Series.

Pre-market Notification Details

Device IDK002177
510k NumberK002177
Device Name:THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant HAEMOSCOPE CORP. 7855 GROSS POINT RD. SUITE G4 Skokie,  IL  60077
ContactEli Cohen
CorrespondentEli Cohen
HAEMOSCOPE CORP. 7855 GROSS POINT RD. SUITE G4 Skokie,  IL  60077
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-19
Decision Date2000-09-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10812747018043 K002177 000

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