{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-007919","form_type":"8-K","ticker":"CODX","cik":"0001692415","company_name":"Co-Diagnostics, Inc.","filed_at":"2025-02-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.468345+00:00","generated_at":"2026-05-26T07:01:17.872279+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Co-Diagnostics withdraws COVID-19 test 510(k) application; to submit enhanced version","bullets":["Withdrew current 510(k) application for Co-Dx PCR COVID-19 Test after FDA feedback on component shelf-life stability.","Plans to submit an enhanced version for OTC clearance after collecting new clinical evaluation data.","Enhanced version to incorporate recent PCR platform developments to improve manufacturing efficiencies.","Pipeline includes upcoming tests for tuberculosis, upper-respiratory multiplex, and HPV.","No specific timeline provided for the new submission."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-007919","json":"https://secwatch.observer/filing/0001493152-25-007919.json","markdown":"https://secwatch.observer/filing/0001493152-25-007919.md","text":"https://secwatch.observer/filing/0001493152-25-007919.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1692415/000149315225007919/0001493152-25-007919-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1692415/000149315225007919/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T07:01:17.872279+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"}