{"url_path":"/fda/devices/510k/K254264","section_key":"summary","section_title":"510(k) Clearance: Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA — Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)","topic":"fda","document":{"doc_type":"510k-clearance","doc_date":"2026-09-04","source_url":"https://api.fda.gov/device/510k.json?search=k_number:%22K254264%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)"},"word_count":38,"has_tables":false,"body_markdown":null}