Zeus Scientific, Inc. - FDA 510(k) Cleared Devices

Zeus Scientific, Inc. is a chemistry and immunology device manufacturer based in McHenry, US. The company specializes in flexible autoimmune and infectious disease testing solutions.

Zeus Scientific has received 135 FDA 510(k) clearances from 135 total submissions since its first clearance in 1976. The company's regulatory portfolio spans microbiology devices and immunology testing systems, including ELISA-based assays and immunofluorescence platforms. The latest clearance on record dates to 2022, reflecting the company's historical contribution to diagnostic device development.

Notable cleared devices include the Zeus IFA ANA HEp-2 Test System, Zeus dIFine immunofluorescence imaging platform, and multiple ELISA test systems for infectious disease serology. The company also offers contract manufacturing and OEM commercialization services for diagnostic products.

This profile represents a historical regulatory record. Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.