Hemochron Signature Elite

System, Multipurpose For In Vitro Coagulation Studies

Accriva Diagnostics, Inc.

The following data is part of a premarket notification filed by Accriva Diagnostics, Inc. with the FDA for Hemochron Signature Elite.

Pre-market Notification Details

Device IDK193041
501k NumberK193041
Device Name:Hemochron Signature Elite
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant Accriva Diagnostics, Inc. 6260 Sequence Drive San Diego,  CA  92121
ContactBrian James
CorrespondentBrian James
Accriva Diagnostics, Inc. 6260 Sequence Drive San Diego,  CA  92121
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyHematology
501k Review PanelHematology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-31
Decision Date2019-11-22

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