Flowflex COVID-19 Antigen Home Test— 510(k) K230828
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K230828 for Flowflex COVID-19 Antigen Home Test, Substantially Equivalent on 2023-11-09. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code QYT
- 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 QYT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.