FDA 510(k)

Hemochron Signature Elite

K-Number: K193041 · 2019-11-22

Decision Date2019-11-22

Product CodeJPA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Hemochron Signature Elite is the device name listed in this FDA 510(k) record. The listed applicant is Accriva Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) 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. The listed applicant is Accriva Diagnostics, Inc.. The 510(k) number is K193041.

When did Hemochron Signature Elite receive FDA 510(k) clearance?

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

Who is the listed applicant for Hemochron Signature Elite?

The FDA 510(k) record lists Accriva Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemochron Signature Elite?

The FDA product code for Hemochron Signature Elite is JPA.

Other records listing Accriva Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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