FDA 510(k)

FilmArray Blood Culture Identification (BCID) Panel

Número K: K181493 · 2018-07-05

Data da decisão2018-07-05

Código do produtoPEN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

FilmArray Blood Culture Identification (BCID) Panel 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 2018-07-05 under 510(k) number K181493. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FilmArray Blood Culture Identification (BCID) Panel?

FilmArray Blood Culture Identification (BCID) Panel is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K181493.

When did FilmArray Blood Culture Identification (BCID) Panel receive FDA 510(k) clearance?

FilmArray Blood Culture Identification (BCID) Panel received FDA 510(k) clearance on 2018-07-05, under 510(k) number K181493.

Who is the listed applicant for FilmArray Blood Culture Identification (BCID) Panel?

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?

The FDA product code for FilmArray Blood Culture Identification (BCID) Panel is PEN.

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Fonte oficial

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