---
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"
generated_at: "2026-05-26T07:01:17.872279+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Co-Diagnostics withdraws COVID-19 test 510(k) application; to submit enhanced version

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-007919
- JSON: https://secwatch.observer/filing/0001493152-25-007919.json
- Plain text: https://secwatch.observer/filing/0001493152-25-007919.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.