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FDA 510(k)

Hemochron Signature Elite

K-Number: K193041 · 2019-11-22

ApplicantAccriva Diagnostics, Inc.
Decision Date2019-11-22
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Hemochron Signature Elite is a medical device manufactured by Accriva Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K193041. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemochron Signature Elite?

Hemochron Signature Elite is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Accriva Diagnostics, Inc.. The 510(k) number is K193041.

When was Hemochron Signature Elite approved by the FDA?

Hemochron Signature Elite received FDA 510(k) clearance on 2019-11-22, under approval number K193041.

What company makes Hemochron Signature Elite?

Hemochron Signature Elite is manufactured by Accriva Diagnostics, Inc..

What is the FDA product code for Hemochron Signature Elite?

The FDA product code for Hemochron Signature Elite is JPA.

Other Devices by Accriva Diagnostics, Inc.

K202101GEM 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, Level 1 and Level 2 K223352Tenderfoot

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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