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 a medical device manufactured by Cue Health, Inc.. It received FDA 510(k) clearance on 2023-11-28 under approval 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. It is manufactured by Cue Health, Inc.. The 510(k) number is K232643.
When was Cue COVID-19 Molecular Test approved by the FDA?
Cue COVID-19 Molecular Test received FDA 510(k) clearance on 2023-11-28, under approval number K232643.
What company makes Cue COVID-19 Molecular Test?
Cue COVID-19 Molecular Test is manufactured by Cue Health, Inc..
What is the FDA product code for Cue COVID-19 Molecular Test?
The FDA product code for Cue COVID-19 Molecular Test is QWB.
Other Devices by Cue Health, Inc.
Related Devices (Code: QWB)
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.