ACON Laboratories

Timeline

1. Jul 10, 2026 FDA FDA 510(k) clearance: Flowflex Plus RSV + Flu A/B + COVID Rapid Test — K261212, Jul 10, 2026. Applicant at approval: ACON Laboratories, Inc. source ↗
2. Nov 26, 2025 FDA FDA 510(k) clearance: Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip — K251697, Nov 26, 2025. Applicant at approval: ACON Laboratories, Inc. source ↗
3. Oct 22, 2025 FDA FDA 510(k) clearance: Flowflex Plus RSV + Flu A/B + COVID Home Test — K251749, Oct 22, 2025. Applicant at approval: ACON Laboratories, Inc. source ↗
4. Oct 10, 2025 FDA FDA 510(k) clearance: On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System — K250085, Oct 10, 2025. Applicant at approval: ACON Labor source ↗
5. May 10, 2025 FDA FDA 510(k) clearance: Flowflex Plus COVID-19 + Flu A/B Home Test — K250377, May 10, 2025. Applicant at approval: ACON Laboratories, Inc. source ↗

FDA records (last 2 years)

• Jul 10, 2026 FDA 510(k) clearance: Flowflex Plus RSV + Flu A/B + COVID Rapid Test — K261212, Jul 10, 2026. Applicant at approval: ACON Laboratories, Inc. source ↗
• Nov 26, 2025 FDA 510(k) clearance: Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip — K251697, Nov 26, 2025. Applicant at approval: ACON Laboratories, Inc. source ↗
• Oct 22, 2025 FDA 510(k) clearance: Flowflex Plus RSV + Flu A/B + COVID Home Test — K251749, Oct 22, 2025. Applicant at approval: ACON Laboratories, Inc. source ↗
• Oct 10, 2025 FDA 510(k) clearance: On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System — K250085, Oct 10, 2025. Applicant at approval: ACON Laboratories, Inc. source ↗
• May 10, 2025 FDA 510(k) clearance: Flowflex Plus COVID-19 + Flu A/B Home Test — K250377, May 10, 2025. Applicant at approval: ACON Laboratories, Inc. source ↗