FDA 510(k)

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

Numéro K : K160457 · 2016-03-15

Date de décision2016-03-15

Code produitPEN

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K160457. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K160457.

When did FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch receive FDA 510(k) clearance?

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch received FDA 510(k) clearance on 2016-03-15, under 510(k) number K160457.

Who is the listed applicant for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

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

What is the FDA product code for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

The FDA product code for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is PEN.

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Source officielle

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