# FDA WARNING_LETTER - ikcon investments, inc  - February 11, 2021

Source: https://www.keypedia.com/records/warning_letter/ikcon-investments-inc/f9ec1ba7-b361-479c-be28-157c1f05ade3

> FDA WARNING_LETTER for ikcon investments, inc  on February 11, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ikcon investments, inc 
- Inspection Date: 2021-02-11
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On March 25, 2021, the FDA issued a Warning Letter to a firm operating websites www.ikconmedical.com and www.akcutestshop.com, following reviews on February 3, 4, and 11, 2021. The FDA found the firm was selling "Akcutest COVID-19 Antibody Test" and "Lumigenik COVID-19 Antigen Rapid Test" products, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

These products are deemed devices under section 201(h) of the Act, 21 U.S.C. § 321(h). They are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks required premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the FDA of intent to commercially distribute, as required by section 510(k).

Additionally, the "Akcutest Kit" is misbranded under section 502(a) of the Act, 21 U.S.

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/ikcon-investments-inc/e79baa0d-8d08-4d8b-ad44-f9bfc85fe92a

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7