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FDA 510(k)

Tenderfoot

K-Number: K223352 · 2023-03-02

ApplicantAccriva Diagnostics, Inc.
Decision Date2023-03-02
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tenderfoot is a medical device manufactured by Accriva Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-03-02 under approval number K223352. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tenderfoot?

Tenderfoot is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Accriva Diagnostics, Inc.. The 510(k) number is K223352.

When was Tenderfoot approved by the FDA?

Tenderfoot received FDA 510(k) clearance on 2023-03-02, under approval number K223352.

What company makes Tenderfoot?

Tenderfoot is manufactured by Accriva Diagnostics, Inc..

What is the FDA product code for Tenderfoot?

The FDA product code for Tenderfoot is FMK.

Other Devices by Accriva Diagnostics, Inc.

K193041Hemochron Signature Elite 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

Related Devices (Code: FMK)

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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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