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FilmArray Respiratory Panel 2 plus (RP2plus)

DEN170017 Class II Direct
Decision Date
2017-11-24
Sponsor / Applicant
Biofire Diagnostics, LLC

Technical Specification

510(k) Submission ID DEN170017
Product Code PZF
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 866.4001
Decision Date 2017-11-24
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

FilmArray Respiratory Panel 2 plus (RP2plus) received FDA 510(k) clearance under submission number DEN170017, sponsored by Biofire Diagnostics, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2017-11-24.

Classification & Regulation

This clearance is catalogued under FDA product code PZF and 21 CFR 866.4001, within the Pathology review panel as a Class II device.