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.
Summary
ACON Laboratories' Flowflex Plus RSV + Flu A/B + COVID Rapid Test is filed under SCA, multi-analyte respiratory virus antigen detection tests. The record doesn't give sample types.
Class II, 21 CFR 866.3987. Microbiology is both the classification panel and the review panel. The submission type is listed as Dual Track.
ACON filed from San Diego, California. The decision came 87 calendar days after FDA received it (April 14 to July 10, 2026).
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Product 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.