TEG 6s Hemostasis System

System, Multipurpose For In Vitro Coagulation Studies

Haemonetics Corporation

The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Teg 6s Hemostasis System.

Pre-market Notification Details

Device IDK160502
510k NumberK160502
Device Name:TEG 6s Hemostasis System
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant Haemonetics Corporation 400 Wood Road Braintree,  MA  02184
ContactPaige Sweeney
CorrespondentPaige Sweeney
Haemonetics Corporation 400 Wood Road Braintree,  MA  02184
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-23
Decision Date2017-04-19
Summary:summary

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