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FDA 510(k)

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

K-Number: K221613 · 2022-10-03

ApplicantOwen Mumford, Ltd.
Decision Date2022-10-03
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is a medical device manufactured by Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-10-03 under approval number K221613. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is a medical device that received FDA 510(k) clearance on 2022-10-03. It is manufactured by Owen Mumford, Ltd.. The 510(k) number is K221613.

When was Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets approved by the FDA?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets received FDA 510(k) clearance on 2022-10-03, under approval number K221613.

What company makes Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is manufactured by Owen Mumford, Ltd..

What is the FDA product code for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

The FDA product code for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is QRL.

Related Clinical Trials

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Related Devices (Code: QRL)

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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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