I have a million dollar question that i hope you can help me. We are a manufacturer of Air purifiers with a 510 k approved for viruses MS2, / PHI-x174 and additional bacteria. We want to add Covid-2 /19 to the 510 K. Note that the Air purifier has not changed since its design. no change to the device has occurred. We just recently ran a test for Covid (California Certified Lab) and the log reduction exceeded our expectations. We want to add the Covid virus taking into account the MS2 is a good surrogate for Covid-19 Question would this require a new 510 k, a Special 510k or just a memo to file. Thank you for your assistance
Albert C
Albert C
