Quote:
The product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k

In order for any "Manufacturer" or "Re-Manufacturer" of any device for medical use in the United States, must submit an application ("510-K"

to the FDA for license to manufacture, sell and distribute the product.

My guess, is one of the companies that Innova acquired had not submitted the "510-K". Innova can submit a request for EUA while the application for the 510-K is submitted and under review. Most other manufactur's for this Covid-19 are using the "EUA" (Emergency Use Authorization" all of the "Vaccines" are only authorized by the FDA "NOT APPROVED"

The following quote by the FDA in their letter,

Quote:
To date, the FDA has not received reports of injuries or death associated with use of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.

which is key. One has to only look at the Vaccine injury report

Quote:
About VAERS
Healthcare professionals are required to report certain adverse events..

It is not the end of the world. My personal experience , I was a Field Engineer on a 510-K performing data collection, calibration and documenting repairs for the first "Full Field Digital Mammography Unit" with GE Healthcare for 2 years. there were 3 of us, one field engineer before and one after me..

The bottom line, someone did not submit their 510-K. I worked with 2 Medical Physicist's on "False Positive and False Negative" reporting requirements.

Regards

Sunny:>

))