Flowflex Plus COVID-19 + Flu A/B Home Test— 510(k) K250377
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K250377 for Flowflex Plus COVID-19 + Flu A/B Home Test, Substantially Equivalent on 2025-05-10. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code SCA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3987
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code SCA
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- K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- K251538 — Status COVID-19/Flu A&B
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
More clearances from ACON Laboratories, Inc.
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