![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » PerkinElmer Receives Clearance for Two Assays
PerkinElmer Receives Clearance for Two Assays
![ClearanceStamp_Orange.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Orange.gif?t=1609798625&width=430)
July 26, 2018
The FDA granted 510(k) clearance for two new PerkinElmer assays developed by its Euroimmun subsidiary.
The assays screen and diagnose anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis, disorders that can be hard to diagnose.
The two assays provide reliable ANCA screening results and eliminate the need to run several analyses for each sample.
Upcoming Events
-
21Oct