FDA 510(k)

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

K-Nummer: K213362 · 2023-03-22

Entscheidungsdatum2023-03-22

ProduktcodeQVR

BeratungsausschussIM

EntscheidungSubstantially Equivalent

Produktübersicht

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Defense, LLC. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K213362. The device is classified under product code QVR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Biofire Defense, LLC. The 510(k) number is K213362.

When did BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel receive FDA 510(k) clearance?

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel received FDA 510(k) clearance on 2023-03-22, under 510(k) number K213362.

Who is the listed applicant for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

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

What is the FDA product code for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

The FDA product code for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is QVR.

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Verwandte Geräte (Code: QVR)

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Offizielle Quelle

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