Zymo Research - FDA 510(k) Cleared Devices

Zymo Research, is a biomedical products and services company with a manufacturing facility in Irvine, California. The company specializes in molecular biology solutions, including sample collection, nucleic acid purification, and next-generation sequencing services. Founded over 30 years ago, Zymo Research serves research, diagnostic, and clinical markets globally.

The company has received 2 FDA 510(k) clearances from 2 total submissions, with all submissions focused on Microbiology devices. Clearances span from 2020 to 2023. Notable cleared devices include specimen collection kits designed for molecular diagnostic applications.

Zymo Research is currently inactive in the FDA 510(k) clearance database, with no submissions recorded in the past five years. This profile serves as a historical regulatory record of the company's medical device activities.

For detailed information on specific device names, product codes, and clearance dates, review the complete 510(k) submission history in the FDA database.