Cue COVID-19 Molecular Test
FDA 510(k) clearance K232643 · decided 2023-11-28
Clearance details
- K-number
- K232643
- Device name
- Cue COVID-19 Molecular Test
- Applicant
- Cue Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-30
- Decision date
- 2023-11-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QWB
- Device class
- 2
- Regulation number
- 866.3984
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Metrix COVID Test; Metrix COVID Test Pro (K253453) | Aptitude Medical Systems, Inc. | 2026-08-07 |
| Cue COVID-19 Molecular Test (DEN220028) | Cue Health, Inc. | 2023-06-06 |
Recalls involving this device
No recalls on record reference this clearance.