meddevicedb.com FDA Device Reference

FDA Product Code

FDA Product Code PZF — Clearance Directory

Device Class
Class II
Assigned Panel
Pathology
21 CFR Citation
866.4001

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN170017 FilmArray Respiratory Panel 2 plus (RP2plus) Biofire Diagnostics, LLC 2017-11-24 Direct —

Product code PZF · Class II · Pathology. Data: openFDA.