Acon Laboratories is one of 13039 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Acon Laboratories - FDA 510(k) Cleared Devices
Recent clearances: On Call Pro Blood Glucose Monitoring System
1
Total
1
Cleared
0
Denied
Acon Laboratories, is a global medical device manufacturer headquartered in San Diego, California. The company specializes in diagnostic and point-of-care testing products distributed across hospitals, clinical laboratories, physician offices, and pharmacies worldwide. Acon operates an FDA-registered manufacturing facility and serves customers in over 130 countries.
Acon has received 1 FDA 510(k) clearance from 1 total submission, with its cleared device in the Chemistry category. The company's regulatory activity dates to 2016. As a historical record, Acon's most recent clearance was in 2016, reflecting the company's established presence in diagnostic device development.
The company's product portfolio includes blood glucose monitoring systems, point-of-care testing devices, immunoassays, molecular diagnostics, and animal health products. Notable brands include On Call blood glucose meters, Flowflex rapid diagnostic tests, and HealthyMe urinary tract infection reagent strips. Acon also provides contract manufacturing and original equipment manufacturer (OEM) services for custom diagnostic devices.
Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.
FDA 510(k) Regulatory Record - Acon Laboratories
1 devices