Kachingamore, You’re confused on the differen
Post# of 9108
![](/assets/46931549/no_avatar_available_thumb.jpg)
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
![Like This Post](/images/thumb-up.png)
![Dislike This Post](/images/thumb-down.png)