Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs

Warning LetterOpen

Dennis Dannel Founder and CEO Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs 424 S. Roadway New Orleans , LA 70124 United States sales@tmtestkits.comIssued Mar 24, 2021Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateMar 24, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs
Location: Dennis Dannel Founder and CEO Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs 424 S. Roadway New Orleans , LA 70124 United States sales@tmtestkits.com
FEI Number: N/A
Country: United States
Issue Date: March 24, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Drugs
Status: Open

Summary

Tresmonet Technologies and TM Testing sold COVID-19 rapid antibody test kits directly to consumers for at-home use without FDA approval, clearance, or authorization, rendering the product adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket approval (PMA), investigational device exemption (IDE), or 510(k) clearance before marketing the device, and did not notify FDA of its intent to introduce the device into commercial distribution as required by section 510(k). The violation was identified during FDA website reviews conducted in August 2020 and March 2021.

Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs FDA Warning Letter, March 24, 2021