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FDA 510(k)

BIOFIRE SPOTFIRE Respiratory (R) Panel

K-Number: K213954 · 2023-02-03

ApplicantBiofire Diagnostics
Decision Date2023-02-03
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE SPOTFIRE Respiratory (R) Panel is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K213954. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIRE SPOTFIRE Respiratory (R) Panel?

BIOFIRE SPOTFIRE Respiratory (R) Panel is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Biofire Diagnostics. The 510(k) number is K213954.

When did BIOFIRE SPOTFIRE Respiratory (R) Panel receive FDA 510(k) clearance?

BIOFIRE SPOTFIRE Respiratory (R) Panel received FDA 510(k) clearance on 2023-02-03, under 510(k) number K213954.

Who is the listed applicant for BIOFIRE SPOTFIRE Respiratory (R) Panel?

The FDA 510(k) record lists Biofire Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOFIRE SPOTFIRE Respiratory (R) Panel?

The FDA product code for BIOFIRE SPOTFIRE Respiratory (R) Panel is QOF.

Other records listing Biofire Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniK243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelK241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniK232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

View all 21 devices →

Related Devices (Code: QOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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