Home / 510(k) Clearances / DEN220028

510(k) DEN220028

Cue COVID-19 Molecular Test by Cue Health, Inc. — Product Code QWB

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 6, 2023
Date Received
May 2, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Device Class
Class II
Regulation Number
866.3984
Review Panel
MI
Submission Type

An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.

Other clearances by Cue Health, Inc.

  • K232643 — Cue COVID-19 Molecular Test (November 28, 2023)

Other clearances for product code QWB

  • K232643 — Cue COVID-19 Molecular Test (November 28, 2023)