Acon Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 92
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2322-2015 | Class III | Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: | June 17, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | November 26, 2025 |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | October 22, 2025 |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ket | October 10, 2025 |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | May 10, 2025 |
| K232715 | Distinct® Digital Pregnancy Test | May 31, 2024 |
| K233373 | Flowflex® Plus COVID-19 Home Test | April 19, 2024 |
| K230828 | Flowflex COVID-19 Antigen Home Test | November 9, 2023 |
| K193318 | Distinct® Early Detection Pregnancy Test | August 20, 2020 |
| K192175 | On Call Express II Blood Glucose Monitoring System | October 17, 2019 |
| K191038 | On Call Express Voice Blood Glucose Monitoring System | June 12, 2019 |
| K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | October 3, 2018 |
| K180504 | Mission Lipid Panel Monitoring System | March 28, 2018 |
| K180196 | On Call Express Mobile Blood Glucose Monitoring System | March 7, 2018 |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | July 11, 2017 |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis | July 6, 2017 |
| K161867 | On Call Pro Blood Glucose Monitoring System | August 5, 2016 |
| K151595 | On Call Express Pro Blood Glucose Monitoring System | September 5, 2015 |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Contr | May 11, 2015 |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | April 30, 2015 |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | December 22, 2014 |