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Posted On: 04/04/2018 7:33:11 PM
Post# of 9144
Re: kachingamore #4406
Kachingamore,
You’re confused on the difference between FDA 510k approval and petri- based and ELISA Diagnostics. Petri have been grandfathered in for many years for all producers. As for the N-Assay, it’s listed as a modified ELISA, so it should not need 510k. FDA inspection for a facility has nothing to do with 510k.
Scott
You’re confused on the difference between FDA 510k approval and petri- based and ELISA Diagnostics. Petri have been grandfathered in for many years for all producers. As for the N-Assay, it’s listed as a modified ELISA, so it should not need 510k. FDA inspection for a facility has nothing to do with 510k.
Scott
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