Hach Company - FDA 510(k) Cleared Devices

Hach Company, is a water analysis and monitoring solutions provider with a manufacturing facility in Elkhart, Indiana. The company specializes in laboratory instruments, reagents, chemistries, and analytical systems for water quality testing across municipal, industrial, and environmental applications.

Hach has received 4 FDA 510(k) clearances from 4 total submissions. The company's regulatory focus centers on Gastroenterology & Urology devices, which represent the dominant category of its cleared submissions. FDA 510(k) clearances span from 2004 to 2017, establishing a historical regulatory record in specialized medical device categories.

Hach's cleared devices include monitoring systems, reagent strips, and diagnostic test products designed for clinical and sterilization applications. The company's product portfolio reflects expertise in chemistry-based detection and validation technologies for healthcare environments.

This company profile is maintained as a historical regulatory record. For detailed information on specific device names, product codes, and individual clearance dates, please review the complete 510(k) submission history.