Flowflex Plus RSV + Flu A/B + COVID Rapid Test— 510(k) K261212
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K261212 for Flowflex Plus RSV + Flu A/B + COVID Rapid Test, Substantially Equivalent on 2026-07-10. 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
- Dual Track
- Location
- San Diego, CA, US
Recent devices under product code SCA
view all- K251085 — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
- 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
- K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
More clearances from ACON Laboratories, Inc.
view all- K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test
- K232715 — Distinct® Digital Pregnancy Test
- K233373 — Flowflex® Plus COVID-19 Home Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.