Crunch,
I included the following quote from the FDA contained in their letter. It points to directly of the lack of submission of the required 510-K application to manufacture, sell and distribute a medical product in the United States.
Regards
Sunny:>
))
I included the following quote from the FDA contained in their letter. It points to directly of the lack of submission of the required 510-K application to manufacture, sell and distribute a medical product in the United States.
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.
Regards
Sunny:>
))
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