510(k) K232643
- Device
- Cue COVID-19 Molecular Test
- Applicant
- Cue Health, Inc.
- 510(k) number
- K232643
- Product code
- QWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-28
- Date received
- 2023-08-30
- Regulation
- 866.3984
- Classification name
- Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sharon Young
- Address
- 4980 Carroll Canyon Rd. Suite 100 San Diego CA US 92121 92121
FDA Registration Numbers#
- 3034617817
Source Documents#
Other 510(k) Records For Product Code QWB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220028 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023-06-06 |