ACON Laboratories, Inc.
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories7
Latest Approval2025-11-26
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | GTY | 2025-11-26 | View |
| 510(k) | K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | SCA | 2025-10-22 | View |
| 510(k) | K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | NBW | 2025-10-10 | View |
| 510(k) | K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | SCA | 2025-05-10 | View |
| 510(k) | K232715 | Distinct® Digital Pregnancy Test | LCX | 2024-05-31 | View |
| 510(k) | K233373 | Flowflex® Plus COVID-19 Home Test | QYT | 2024-04-19 | View |
| 510(k) | K230828 | Flowflex COVID-19 Antigen Home Test | QYT | 2023-11-09 | View |
| 510(k) | K193318 | Distinct® Early Detection Pregnancy Test | LCX | 2020-08-20 | View |
| 510(k) | K192175 | On Call Express II Blood Glucose Monitoring System | NBW | 2019-10-17 | View |
| 510(k) | K191038 | On Call Express Voice Blood Glucose Monitoring System | NBW | 2019-06-12 | View |
| 510(k) | K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | NBW | 2018-10-03 | View |
| 510(k) | K180504 | Mission Lipid Panel Monitoring System | CHH | 2018-03-28 | View |
| 510(k) | K180196 | On Call Express Mobile Blood Glucose Monitoring System | NBW | 2018-03-07 | View |
| 510(k) | K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | CHH | 2017-07-11 | View |
| 510(k) | K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis | JIN | 2017-07-06 | View |
No matching devices.