---
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"
generated_at: "2026-06-01T04:21:17.991834+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Co-Diagnostics files first FDA 510(k) for Co-Dx PCR Pro platform and OTC COVID-19 test

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-023796
- JSON: https://secwatch.observer/filing/0001493152-24-023796.json
- Plain text: https://secwatch.observer/filing/0001493152-24-023796.txt

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