GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), DirectCHECK ACT+ Whole Blood Control, Level 1 And Level 2, DirectCHECK ACT-LR Whole Blood Control

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 Gem Hemochron 100 System, Gem Hemochron 100 Activated Clotting Time Plus Test (act+), Gem Hemochron 100 Low Range Activated Clotting Time Test (act-lr), Directcheck Act+ Whole Blood Control, Level 1 And Level 2, Directcheck Act-lr Whole Blood Control.

Pre-market Notification Details

Device IDK202101
510k NumberK202101
Device Name:GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), DirectCHECK ACT+ Whole Blood Control, Level 1 And Level 2, DirectCHECK ACT-LR Whole Blood Control
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  
Subsequent Product CodeGGN
Subsequent Product CodeJBP
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-29
Decision Date2021-12-29

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