From 10Q: It is important to note that QMC is collaborating with a leading university in the medical field and intends to initially pursue the FDA EUA while also pursuing the FDA 510(k) clearance of its test platform for non-covid related testing. QMC also intends to pursue regulatory approvals in one or more foreign jurisdictions.
Could this leading university is Harvard due to connections with Michael Mina via Innova? or simply TXU. If its non-covid related testing platform/kit not sure how FDA EUA applicable.
FDA EUA:Federal Drug Administration emergency use authorization (“EUA”)
FDA 510(k) clearance: FDA clearance through the 510(k) process means the agency is in agreement with the manufacturer that a medical device is similar to a previously approved product.
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