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FDA 510(k)

Agilon Strip

K-Number: K193487 · 2020-03-30

ApplicantBiogennix, LLC
Decision Date2020-03-30
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Agilon Strip is the device name listed in this FDA 510(k) record. The listed applicant is Biogennix, LLC. It received FDA 510(k) clearance on 2020-03-30 under 510(k) number K193487. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Agilon Strip?

Agilon Strip is a medical device that received FDA 510(k) clearance on 2020-03-30. The listed applicant is Biogennix, LLC. The 510(k) number is K193487.

When did Agilon Strip receive FDA 510(k) clearance?

Agilon Strip received FDA 510(k) clearance on 2020-03-30, under 510(k) number K193487.

Who is the listed applicant for Agilon Strip?

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

What is the FDA product code for Agilon Strip?

The FDA product code for Agilon Strip is MQV.

Other records listing Biogennix, LLC 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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Related Devices (Code: MQV)

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.

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