ACON Laboratories, Inc. - FDA 510(k) Cleared Devices

ACON Laboratories, Inc. is a global medical device manufacturer headquartered in San Diego, California. The company develops and manufactures diagnostic and point-of-care testing devices for hospitals, clinical laboratories, physician offices, blood banks, pharmacies, and veterinary clinics. ACON operates in over 130 countries and maintains FDA-registered manufacturing facilities with ISO 13485 certification.

ACON has received 85 FDA 510(k) clearances from 85 total submissions since 1998, with no denied submissions. The company specializes in chemistry devices, including blood glucose monitoring systems, pregnancy tests, lipid and cholesterol monitoring systems, and urinalysis reagent strips. The most recent clearance was in 2025, demonstrating continued regulatory activity and product innovation.

Notable product lines include the On Call® blood glucose meter family, Mission® lipid and cholesterol monitoring systems, Distinct® pregnancy tests, and Flowflex® rapid diagnostic tests for infectious diseases. ACON also offers contract manufacturing and original equipment manufacturer (OEM) services for custom diagnostic devices.

Explore the complete list of cleared device names, product codes, and clearance dates in the FDA 510(k) database.

Regulatory submissions have been managed by Mcra, LLC, MCRA and MCRA, an IQVIA Company.