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BioFire Respiratory Panel 2.1 (RP2.1)

DEN200031 Class II Direct
Decision Date
2021-03-17
Sponsor / Applicant
Biofire Diagnostics, LLC

Technical Specification

510(k) Submission ID DEN200031
Product Code QOF
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.3981
Decision Date 2021-03-17
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

BioFire Respiratory Panel 2.1 (RP2.1) received FDA 510(k) clearance under submission number DEN200031, sponsored by Biofire Diagnostics, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2021-03-17.

Classification & Regulation

This clearance is catalogued under FDA product code QOF and 21 CFR 866.3981, within the Microbiology review panel as a Class II device.