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FDA 510(k)

Cue COVID-19 Molecular Test

K-Number: K232643 · 2023-11-28

ApplicantCue Health, Inc.
Decision Date2023-11-28
Product CodeQWB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Cue COVID-19 Molecular Test is the device name listed in this FDA 510(k) record. The listed applicant is Cue Health, Inc.. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K232643. The device is classified under product code QWB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cue COVID-19 Molecular Test?

Cue COVID-19 Molecular Test is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Cue Health, Inc.. The 510(k) number is K232643.

When did Cue COVID-19 Molecular Test receive FDA 510(k) clearance?

Cue COVID-19 Molecular Test received FDA 510(k) clearance on 2023-11-28, under 510(k) number K232643.

Who is the listed applicant for Cue COVID-19 Molecular Test?

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

What is the FDA product code for Cue COVID-19 Molecular Test?

The FDA product code for Cue COVID-19 Molecular Test is QWB.

Related Devices (Code: QWB)

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.

K253453Metrix COVID Test; Metrix COVID Test ProAptitude Medical Systems, Inc.

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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