Phadia AB - FDA 510(k) Cleared Devices

Phadia AB is a medical products company headquartered in Uppsala, Sweden. The company develops, manufactures, and markets blood test systems for clinical diagnosis and monitoring of allergy, asthma, and autoimmune diseases.

Phadia AB received 32 FDA 510(k) clearances from 32 total submissions, with no denied submissions on record. The company's regulatory focus is entirely on Immunology devices. Clearances span from 2007 to 2022, establishing a consistent track record in immunoassay and allergen testing technologies.

The company's cleared devices include immunoassay systems for autoimmune markers, allergen component testing, and celiac disease diagnostics. Notable product lines encompass the ImmunoCAP Allergen series and EliA immunoassay platforms. Now part of Thermo Fisher Scientific since 2011, Phadia's regulatory record remains a historical reference for Immunology device development.

Explore the complete list of device names, product codes, and clearance dates in the database.