FDA Product Code
FDA Product Code QWB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3984
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | 2026-08-07 | Traditional | PDF ↗ |
| K232643 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023-11-28 | Traditional | PDF ↗ |
| DEN220028 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023-06-06 | Direct | — |
Product code QWB · Class II · Microbiology. Data: openFDA.