{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-023796","form_type":"8-K","ticker":"CODX","cik":"0001692415","company_name":"Co-Diagnostics, Inc.","filed_at":"2024-06-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.631261+00:00","generated_at":"2026-06-01T04:21:17.991834+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Co-Diagnostics files first FDA 510(k) for Co-Dx PCR Pro platform and OTC COVID-19 test","bullets":["FDA receives 510(k) submission for Co-Dx PCR Pro instrument and OTC COVID-19 test.","Company plans to shortly pursue point-of-care (POC) clearance for the same test.","Other tests in pipeline include tuberculosis, HPV, strep A, and a respiratory multiplex (flu A/B, COVID-19, RSV).","CEO Dwight Egan says 510(k) clearance would validate the platform and enable commercialization."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-023796","json":"https://secwatch.observer/filing/0001493152-24-023796.json","markdown":"https://secwatch.observer/filing/0001493152-24-023796.md","text":"https://secwatch.observer/filing/0001493152-24-023796.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1692415/000149315224023796/0001493152-24-023796-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1692415/000149315224023796/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T04:21:17.991834+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}