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Found 2 results

510(k) Data Aggregation

K Number

Device Name

FilmArray NGDS Warrior Panel

Manufacturer

BioFire Defense, LLC

Date Cleared

2017-06-22

(90 days)

Product Code

Regulation Number

N/A

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

FilmArray NGDS Warrior Panel

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Device Name

FilmArray NGDS Warrior Panel

Manufacturer

BioFire Defense, LLC

Date Cleared

2017-02-14

(120 days)

Product Code

Regulation Number

N/A

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

FilmArray NGDS Warrior Panel

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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