Cue COVID-19 Molecular Test— 510(k) K232643
Substantially EquivalentCue Health, Inc.
FDA 510(k) clearance K232643 for Cue COVID-19 Molecular Test, Substantially Equivalent on 2023-11-28. Applicant: Cue Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Cue Health, Inc.
- Product code
- Code QWB
- Device class
- Class 2
- Regulation
- 21 CFR 866.3984
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code QWB
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