FDA 510(k)

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

Número K: K161816 · 2017-03-28

Data da decisão2017-03-28

Código do produtoMDB

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-03-28 under 510(k) number K161816. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is a medical device that received FDA 510(k) clearance on 2017-03-28. The listed applicant is bioMerieux, Inc.. The 510(k) number is K161816.

When did BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO receive FDA 510(k) clearance?

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO received FDA 510(k) clearance on 2017-03-28, under 510(k) number K161816.

Who is the listed applicant for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

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

What is the FDA product code for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

The FDA product code for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is MDB.

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Fonte oficial

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